Knotless anchor insertion

ABSTRACT

Various exemplary systems and devices for knotless anchor insertion and methods of knotless anchor insertion are provided. In general, an inserter tool is configured for knotless anchor insertion in a soft tissue repair surgical procedure. The inserter tool is configured to insert an anchor into a bone of a patient to secure a soft tissue relative to the bone. A suture coupled to the soft tissue is secured relative to the bone by being trapped between an exterior surface of the anchor and a bone surface defining a hole in the bone in which the anchor is positioned.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Prov. Pat. App. No.63/017,009 entitled “Knotless Anchor Insertion” filed Apr. 29, 2020,which is hereby incorporated by reference in its entirety.

FIELD

The present disclosure relates generally to knotless anchor insertion.

BACKGROUND

A variety of injuries and conditions require repair of soft tissuedamage, or reattachment of soft tissue to bone and/or surroundingtissue. For example, when otherwise healthy tissue has been torn awayfrom a bone, such as a labrum tearing away from a glenoid (shoulderinstability), surgery is often required to reattach the tissue to thebone, to allow healing and a natural reattachment to occur. A number ofdevices and methods have been developed for performing these surgicalrepairs. Some of the more successful methods including the use of suturefixation members, such as suture anchors, which typically include ananchor body having a suture attachment feature and a tissue or boneengaging feature for retaining the suture anchor within or adjacent tothe tissue or bone. Depending on the specific injury, one or more sutureanchors connected to, or interconnected by, one or more segment ofsuture, may be used to perform the repair.

Surgery can also be required when a tear occurs in the substance of asingle type of tissue. Sutures can also be used in conjunction with oneor more suture anchors to repair such tissue tears. Sutures can befastened to suture anchors and to tissue using knots tied by the surgeonduring a repair procedure, or using “knotless” devices and methods,where one or more anchors and one or more sutures can be connected andtensioned without the surgeon needing to tie knots during the surgery.Knotless anchoring is of particular utility for minimally invasivesurgeries, such as endoscopic or arthroscopic repairs, where the surgeonremotely manipulates the suture at the surgical site using toolsinserted through a small diameter cannula, an endoscopic tube, orotherwise percutaneously, which can make the knotting process difficultand tedious. However, while knotless anchors can be very effective inreattaching soft tissue to bone, the small size of the anchor andpatient anatomy can make it difficult to locate and insert the anchorinto the bone hole. Additionally, visualization of the hole can bedifficult due to challenging angles and the tight nature of the jointspace.

Accordingly, there remains a need for improved knotless anchorinsertion.

SUMMARY

In general, systems and devices for knotless anchor insertion andmethods of knotless anchor insertion are provided.

In one aspect, a surgical system is provided that in one embodimentincludes a handle, an outer shaft extending distally from the handle andincluding an inner lumen, and an inner shaft extending distally from thehandle. The inner shaft is positioned in the inner lumen of the outershaft, a distal end of the inner shaft is positioned distal to an opendistal end of the outer shaft, and the distal end of the inner shaft hasa notch formed therein that is configured to seat a suture therein. Thesystem also includes an anchor configured to be implanted in bone. Theanchor includes an inner lumen, and the inner shaft is positioned in theinner lumen of the anchor. With the distal end of the inner shaftpositioned in a bone hole, the outer shaft is configured to translatelongitudinally and distally relative to the inner shaft and therebycause the anchor to translate longitudinally and distally into the bonehole.

The system can vary in any number of ways. For example, after thetranslation of the outer shaft, the outer shaft and the inner shaft canbe configured to simultaneously translate longitudinally and proximallyrelative to the anchor in the bone hole. For another example, prior tothe translation of the outer shaft, a distal end of the outer shaft canabut a proximal end of the anchor having the inner shaft positioned inthe inner lumen of the anchor.

For yet another example, the notch can have an open distal end and aclosed proximal end. The system can also include a pliable member thatextends along the open distal end of the notch so as to define anenclosed passage in cooperation with the inner shaft, and the enclosedpassage can be configured to seat the suture therethrough. The pliablemember can be configured to bend such that the enclosed passage isopened to allow the suture to be released. The pliable member can bemade from a shape memory or superelastic material.

For still another example, the notch can extend longitudinally along alongitudinal axis of the inner shaft. For yet another example, the notchcan define a tortuous path. For still another example, the anchor canhave a plurality of bone-engaging surface features configured to engagea wall of the bone hole to secure the anchor in the bone hole. For yetanother example, a distal portion of the inner shaft including the notchcan be made from a shape memory or superelastic material.

For another example, the inner shaft can include distal arms that definethe notch therebetween. The notch can have an open distal end, and thearms can each be configured to flex radially outward in response to asuture passing through the open distal end. The arms can be made from ashape memory or superelastic material.

For yet another example, the system can include the suture seated in thenotch. The suture can be seated in the notch prior to the distal end ofthe inner shaft being positioned in the bone hole and can be seated inthe notch after the translation of the outer shaft such that the anchortraps the suture between an exterior surface of the anchor and a wall ofthe bone hole. The system can include a suture retention member at thehandle, and the suture retention member can be configured to releasablyretain the suture therein. After the translation of the outer shaft, theinner shaft can be configured to translate longitudinally and proximallyrelative to the anchor in the bone hole, the notch can have an opendistal end, and the suture can be configured to pass out of the notchthrough the open distal end in response to the longitudinal and proximaltranslation of the inner shaft.

For still another example, the system can include a locking mechanismconfigured to move from a locked position, in which the outer shaft isprevented from translating longitudinally and distally relative to theinner shaft, to an unlocked position, in which the outer shaft isallowed to translate longitudinally and distally relative to the innershaft.

For yet another example, the system can include a strike cap extendingproximally from the handle and being operatively coupled to the outershaft, and the strike cap can be configured to be hit by a tool andthereby cause the outer shaft to translate longitudinally and distallyrelative to the inner shaft. The system can include a locking mechanismconfigured to move from a locked position, in which the outer shaft isprevented from translating longitudinally and distally relative to theinner shaft in response to a hit on the strike cap, to an unlockedposition, in which the outer shaft is allowed to translatelongitudinally and distally relative to the inner shaft in response to ahit on the strike cap. The system can include a protective memberconfigured to move from a closed position, in which the protectivemember covers a strike surface of the strike cap, to an open position,in which the protective member does not cover a strike surface of thestrike cap. The protective member can be attached to the handle via ahinge. The hinge can be a living hinge.

For another example, the system can include the suture and a loading aidthat can be configured to releasably couple to the inner shaft and canbe configured to guide the suture into the notch. The loading aid caninclude a first channel configured to guide the suture therethrough andinto the notch formed in the inner shaft with the loading aid releasablycoupled to the inner shaft. The loading aid can have a second channelformed therein that is in communication with the first channel, and theinner shaft can be configured to pass through the second channel duringrelease of the loading aid from the inner shaft. The loading aid can beconfigured to be released from the inner shaft after the suture has beenseated in the notch and before the distal end of the inner shaft ispositioned in the bone hole. The loading aid can include a V-shapeddistal seating groove, and the distal seating groove can be incommunication with the first channel such that the suture is configuredto be seated in the distal seating groove and pass into the firstchannel so as to automatically seat the suture in the notch.

In another embodiment, a surgical system includes an inserter tool, asuture, and an anchor. The inserter tool includes an outer shaft, and aninner shaft. A distal end of the inner shaft has a suture retentionchannel formed therein, and the inner shaft is positioned in the outershaft with the suture retention channel positioned distal to an opendistal end of the outer shaft. The suture is seated in the sutureretention channel. The anchor is configured to be implanted in bone andhaving the inner shaft seated in a cannulated interior thereof. Theanchor is configured to be pushed distally by the outer shaft movingaxially and distally along a longitudinal axis of the inserter toolrelative to the inner shaft and the suture.

The system can have any number of variations. For example, after theaxial movement of the outer shaft, the outer shaft and the inner shaftcan be configured to simultaneously move axially and proximally alongthe longitudinal axis of the inserter tool relative to the anchor andthe suture. For another example, prior to the axial movement of theouter shaft, a distal end of the outer shaft can abut a proximal end ofthe anchor having the inner shaft positioned therein.

For yet another example, the suture retention channel can have an opendistal end and a closed proximal end. The system can include a pliablemember that extends along the open distal end of the suture retentionchannel so as to define an enclosed passage in cooperation with theinner shaft, and the enclosed passage can be configured to seat thesuture therethrough. The pliable member can be configured to bend suchthat the enclosed passage is opened to allow the suture to be released.The pliable member can be made from a shape memory or superelasticmaterial.

For still another example, the suture retention channel can extendlongitudinally along a longitudinal axis of the inner shaft. For anotherexample, the suture retention channel can define a tortuous path.

For yet another example, the inner shaft can include a pair of distalarms that define the suture retention channel therebetween. The sutureretention channel can have an open distal end, and the arms can each beconfigured to flex radially outward in response to the suture passingthrough the open distal end. The arms can be made from a shape memory orsuperelastic material.

For still another example, after the axial movement of the outer shaft,the inner shaft can be configured to move axially and proximally alongthe longitudinal axis of the inserter tool relative to the anchor andthe suture, the suture retention channel can have an open distal end,and the suture can be configured to pass out of the suture retentionchannel through the open distal end in response to the axial andproximal translation of the inner shaft. For another example, the anchorcan have a plurality of bone-engaging surface features configured toengage a wall of a bone hole to secure the anchor in the bone hole.

For yet another example, the inserter tool can include a handle, and theouter and inner shafts can extend distally from the handle. The systemcan include a suture retention member at the handle, and the sutureretention member can be configured to releasably retain the suturetherein.

For another example, the inserter tool can include a locking mechanismconfigured to move from a locked position, in which the outer shaft isprevented from moving axially and distally relative to the inner shaft,to an unlocked position, in which the outer shaft is allowed to moveaxially and distally relative to the inner shaft.

For yet another example, the inserter tool can include a strike capoperatively coupled to the outer shaft, and the strike cap can beconfigured to be hit by a tool and thereby cause the outer shaft to moveaxially and distally relative to the inner shaft. The inserter tool caninclude a locking mechanism configured to move from a locked position,in which the outer shaft is prevented from moving axially and distallyrelative to the inner shaft in response to a hit on the strike cap, toan unlocked position, in which the outer shaft is allowed to moveaxially and distally relative to the inner shaft in response to a hit onthe strike cap. The inserter tool can include a protective memberconfigured to move from a closed position, in which the protectivemember covers a strike surface of the strike cap, to an open position,in which the protective member does not cover a strike surface of thestrike cap. The protective member can be attached to the inserter toolvia a hinge. The hinge can be a living hinge.

For still another example, the system can include a loading aidconfigured to releasably couple to the inner shaft and configured toguide the suture into the suture retention channel. The loading aid caninclude a first channel configured to guide the suture therethrough andinto the suture retention channel formed in the inner shaft with theloading aid releasably coupled to the inner shaft. The loading aid canbe configured to be released from the inner shaft after the suture hasbeen seated in the suture retention channel. The loading aid can have asecond channel formed therein that is in communication with the firstchannel, and the inner shaft can be configured to pass through thesecond channel during the release of the loading aid from the innershaft. The loading aid can include a V-shaped distal seating groove, andthe distal seating groove can be in communication with the first channelsuch that the suture is configured to be seated in the distal seatinggroove and pass into the first channel so as to automatically seat thesuture in the suture retention channel.

In another embodiment, a surgical system includes a handle, an outershaft extending distally from the handle and including an inner lumen,and an inner shaft extending distally from the handle. The inner shaftis positioned in the inner lumen of the outer shaft, and a distal end ofthe inner shaft being positioned distal to an open distal end of theouter shaft. The system also includes a pliable member cooperating withthe distal end of the inner shaft to define an enclosed passage that isconfigured to seat a suture therethrough. The system also includes ananchor configured to be implanted in bone. The anchor includes an innerlumen, and the inner shaft is positioned in the inner lumen of theanchor. The outer shaft is configured to translate relative to the innershaft and thereby cause the anchor to translate distally into a bonehole. The pliable member is configured to bend to open the enclosedpassage.

The system can vary in any number of ways. For example, the pliablemember can be configured to automatically unfold in response tolongitudinal and proximal translation of the inner shaft relative to theanchor and thereby cause the enclosed passage to be opened. For anotherexample, the movement of the outer shaft can be longitudinal and distalrelative to the inner shaft and can be with the distal end of the innershaft positioned in the bone hole, and the translation of the anchor canbe longitudinal and distal into the bone hole.

For another example, after the translation of the outer shaft, the outershaft and the inner shaft can be configured to simultaneously translatelongitudinally and proximally relative to the anchor in the bone hole.

For yet another example, a first end of the pliable member can befixedly attached to the handle, and a second end of the pliable membercan be freely movable relative to the handle and the inner shaft. Thesecond end of the pliable member can be configured to automatically bendrelative to the inner shaft in response to the longitudinal and proximaltranslation of the inner shaft relative to the anchor.

For another example, a proximal surface of the inner shaft can define aproximal side of the enclosed passage, the pliable member can define adistal side of the enclosed passage, and the inner shaft can include apair of opposed distal arms that define left and right sides of theenclosed passage that each extend between the proximal and distal sidesof the enclosed passage. For still another example, the system caninclude a wire operatively coupled to the pliable member, and anactuator at the handle configured to be actuated and thereby cause thewire to move proximally, and the proximal movement of the wire can causebending of the pliable member such that the enclosed passage is opened.

For yet another example, the pliable member can include a metal wire, abraided fabric, or a textile strand. The pliable member can be made froma shape memory or superelastic material.

For another example, prior to the translation of the outer shaft, adistal end of the outer shaft can abut a proximal end of the anchorhaving the inner shaft positioned in the inner lumen of the anchor. Forstill another example, the anchor can have a plurality of bone-engagingsurface features configured to engage a wall of a bone hole to securethe anchor in the bone hole. For another example, the anchor can have aplurality of independent external bone-engaging surface features thathelically extend along a length of the anchor and that are eachconfigured to engage the bone. For still another example, the anchor canhave a plurality of bone-engaging surface features and a plurality ofgussets.

For yet another example, the system can include the suture seatedthrough the enclosed passage. The suture can be seated through theenclosed passage prior to the distal end of the inner shaft beingpositioned in the bone hole and can be seated through the enclosedpassage after the translation of the outer shaft such that the anchortraps the suture between an exterior surface of the anchor and a wall ofthe bone hole. The system can include a suture retention member at thehandle, and the suture retention member can be configured to releasablyretain the suture therein.

For another example, after the translation of the outer shaft, the innershaft can be configured to translate longitudinally and proximallyrelative to the anchor in the bone hole, and the translation of theinner shaft can be configured to automatically cause the bending of thepliable member, thereby allowing release of the suture from the enclosedpassage.

For still another example, the system can include a locking mechanismconfigured to move from a locked position, in which the outer shaft isprevented from translating longitudinally and distally relative to theinner shaft, to an unlocked position, in which the outer shaft isallowed to translate longitudinally and distally relative to the innershaft.

For another example, the system can include a strike cap extendingproximally from the handle and being operatively coupled to the outershaft, and the strike cap can be configured to be hit by a tool andthereby cause the outer shaft to translate longitudinally and distallyrelative to the inner shaft. The system can include a locking mechanismconfigured to move from a locked position, in which the outer shaft isprevented from translating longitudinally and distally relative to theinner shaft in response to a hit on the strike cap, to an unlockedposition, in which the outer shaft is allowed to translatelongitudinally and distally relative to the inner shaft in response to ahit on the strike cap. The system can include a protective memberconfigured to move from a closed position, in which the protectivemember covers a strike surface of the strike cap, to an open position,in which the protective member does not cover a strike surface of thestrike cap. The protective member can be attached to the handle via ahinge. The hinge can be a living hinge.

For another example, the system can include the suture and a loading aidthat can be configured to releasably couple to the inner shaft and isconfigured to guide the suture through the enclosed passage. The loadingaid can include a suture threader.

In another embodiment, a surgical system is provided that includes ahandle, an outer shaft extending distally from the handle and includingan inner lumen, and an inner shaft extending distally from the handle.The inner shaft is positioned in the inner lumen of the outer shaft, adistal end of the inner shaft is positioned distal to an open distal endof the outer shaft, and the distal end of the inner shaft includes firstand second interlocked components that define an enclosed passageconfigured to receive a suture therethrough. The system also includes ananchor configured to be implanted in bone. The anchor includes an innerlumen, and the inner shaft is positioned in the inner lumen of theanchor. Movement of the outer shaft relative to the inner shaft isconfigured to cause the anchor to translate longitudinally and distallyinto a bone hole. The first component is configured to move relative tothe second component, thereby opening the enclosed passage.

The system can vary in any number of ways. For example, the system caninclude the suture, and the movement of the first component can beconfigured to automatically open the enclosed passage, thereby allowingrelease of the suture.

For another example, the movement of the outer shaft relative to theinner shaft can include longitudinal and distal translation of the outershaft relative to the inner shaft before the first component movesrelative to the second component. The movement of the outer shaft can beconfigured to occur with the distal end of the inner shaft positioned ina bone hole, and the suture can extend through the enclosed passageafter the translation of the outer shaft such that the anchor traps thesuture between an exterior surface of the anchor and a wall of the bonehole. The first component can be configured to move relative to thesecond component after the movement of the outer shaft, and the openingof the enclosed passage can allow release of the suture.

In another embodiment, a surgical system is provided that includes abiocompatible anchor configured to be advanced distally into bone. Theanchor has a plurality of independent external bone-engaging surfacefeatures that helically extend along a length of the anchor and that areeach configured to engage the bone. The anchor tapers radially inward ina distal direction such that a diameter of the tapered helical anchor ata proximal end of the anchor is greater than a diameter of the anchor ata distal end of the anchor.

The system can have any number of variations. For example, each of thebone-engaging surface features can extend along an entire length of theanchor. For another example, each of the bone-engaging surface featurescan extend along a partial length of the anchor such that the anchor hasa thread proximal portion and an unthreaded distal portion. For yetanother example, the anchor can be cannulated. For still anotherexample, the bone-engaging surface features can be threads.

For another example, the system can also include an inserter tool thatincludes an outer shaft and an inner shaft, the outer shaft can includean inner lumen, the inner shaft can be positioned in the inner lumen ofthe outer shaft, a distal end of the inner shaft can be positioneddistal to an open distal end of the outer shaft, the distal end of theinner shaft can have a notch formed therein that is configured to seat asuture therein, the inner shaft can be configured to be positioned in aninner lumen of the anchor, and, with the inner shaft position in theinner lumen of the anchor, the outer shaft can be configured totranslate longitudinally and distally relative to the inner shaft andthereby cause the anchor to translate longitudinally and distally into abone hole. After the translation of the outer shaft, the outer shaft andthe inner shaft can be configured to simultaneously translatelongitudinally and proximally relative to the anchor in the bone hole.Prior to the translation of the outer shaft, a distal end of the outershaft can abut the proximal end of the anchor having the inner shaftpositioned in the inner lumen of the anchor. The system can include thesuture, and the translation of the outer shaft can be configured tocause the anchor to trap the suture between the anchor and a wall of thebone hole. The inserter tool can also include a strike cap operativelycoupled to the outer shaft and configured to be hit by a tool andthereby cause the outer shaft to translate longitudinally and distallyrelative to the inner shaft and the anchor to translate longitudinallyand distally into the bone hole.

In another embodiment, a surgical system includes a biocompatible anchorand an inserter tool. A plurality of independent external threads eachextend helically along a length of the anchor and are each configured toengage bone. An inner lumen extends through the anchor. An outerdiameter of the anchor decreases in a distal direction along an entirelength of the anchor. The inserter tool includes an outer shaft and aninner shaft. The outer shaft includes an inner lumen. The inner shaft ispositioned in the inner lumen of the outer shaft. The distal end of theinner shaft has a notch formed therein that is configured to seat asuture therein. The inner shaft extends through the inner lumen of theanchor, and a distal end of the inner shaft is positioned distal to anopen distal end of the outer shaft. The outer shaft is configured totranslate longitudinally and distally relative to the inner shaft andthereby cause the anchor to translate longitudinally and distallyrelative to the inner shaft.

The system can vary in any number of ways. For example, after thetranslation of the outer shaft, the outer shaft and the inner shaft canbe configured to simultaneously translate longitudinally and proximallyrelative to the anchor. For another example, prior to the translation ofthe outer shaft, a distal end of the outer shaft can abut the proximalend of the anchor. For still another example, the bone-engaging surfacefeatures can be threads. For another example, the outer diameter of theanchor can decrease continuously in the distal direction along theentire length of the anchor.

For yet another example, the system can include the suture, thelongitudinal and distal translation of the anchor can be configured toadvance the anchor into a bone hole, and the translation of the outershaft can be configured to cause the anchor to trap the suture betweenthe anchor and a wall of the bone hole. After the translation of theouter shaft, the outer shaft and the inner shaft can be configured tosimultaneously translate longitudinally and proximally relative to theanchor in the bone hole.

For still another example, the inserter tool can include a strike capoperatively coupled to the outer shaft and configured to be hit by atool and thereby cause the outer shaft to translate longitudinally anddistally relative to the inner shaft and the anchor to translatelongitudinally and distally into a bone hole.

In another aspect, a surgical method is provided that in one embodimentincludes positioning a distal end of an inner shaft of an inserter toolin a bone hole. The distal end of the inner shaft has a notch formedtherein, and a suture is seated in the notch. The method also includesmoving an outer shaft of the inserter tool axially and distally relativeto the inner shaft, thereby causing an anchor to slide along the innershaft and be positioned in the bone hole such that the anchor traps thesuture between an exterior surface of the anchor and a wall of the bonehole. The method also includes, after the movement of the outer shaftaxially and distally, moving the outer and inner shafts axially andproximally relative to the anchor such that the inner shaft is removedfrom the bone hole and the anchor and the suture remain in the bonehole.

The method can vary in any number of ways. For example, the axial andproximal movement of the inner shaft can automatically cause the sutureto exit the notch by passing through an open distal end of the notch.

For another example, before the movement of the outer shaft axially anddistally, a pliable member can extend along a distal side of the notchso as to prevent the suture from exiting the notch distally, and theaxial and proximal movement of the inner shaft can automatically causethe pliable member to bend such that the suture can exit the notch. Thepliable member can be made from a shape memory or superelastic material.

For yet another example, the axial and proximal movement of the innershaft can automatically cause the suture to exit the notch by passingthrough an open distal end of the notch, the notch can be defined by apair of distal arms of the inner shaft, and the arms can each flexradially outward in response to the suture passing through the opendistal end of the notch. The arms can be made from a shape memory orsuperelastic material to facilitate radial inward movement of the armsafter the suture passes through the open distal end of the notch.

For another example, the method can include, before the movement of theouter shaft axially and distally, tensioning the suture. For yet anotherexample, the method can include retaining the suture in a sutureretention member at a handle of the inserter tool. For still anotherexample, the method can include, before the movement of the outer shaftaxially and distally, moving a locking mechanism from a locked position,in which the outer shaft is prevented from translating axially anddistally relative to the inner shaft, to an unlocked position, in whichthe outer shaft is allowed to translate axially and distally relative tothe inner shaft.

For another example, striking a strike cap of the inserter tool cancause the movement of the outer shaft axially and distally. The methodcan include, before striking the strike cap, moving a locking mechanismfrom a locked position, in which the outer shaft is prevented fromtranslating axially and distally relative to the inner shaft, to anunlocked position, in which the outer shaft is allowed to translateaxially and distally relative to the inner shaft. The method caninclude, before striking the strike cap, moving a protective member froma closed position, in which the protective member covers a strikesurface of the strike cap, to an open position, in which the protectivemember does not cover a strike surface of the strike cap.

For yet another example, the method can include, before positioning thedistal end of the inner shaft in the bone hole, loading the suture intothe notch by hand.

For still another example, the method can include, before positioningthe distal end of the inner shaft in the bone hole, loading the sutureinto the notch using a tool that is releasably coupled to the innershaft. The tool can include a loading aid, and loading the suture caninclude guiding the suture through a first channel of the loading aidand into the notch. Loading the suture can include guiding the suturefrom the first channel into a second channel of the loading aid that isin communication with the notch such that passing the suture into thesecond channel automatically seats the suture in the notch. Loading thesuture can include guiding the suture from a V-shaped distal seatinggroove of the loading channel and into the first channel. The method caninclude releasing the tool from the inner shaft after the suture hasbeen loaded into the notch using the tool.

In another embodiment, a surgical method includes positioning a distalend of an inner shaft of an inserter tool in a bone hole with a pliablemember attached to the inner shaft. The pliable member and the innershaft cooperate to define an enclosed passage through which a sutureextends. The method also includes moving an outer shaft of the insertertool axially and distally relative to the inner shaft, thereby causingan anchor to slide along the inner shaft and be positioned in the bonehole such that the anchor traps the suture between an exterior surfaceof the anchor and a wall of the bone hole. The method also includes,after the movement of the outer shaft axially and distally, moving theouter and inner shafts axially and proximally relative to the anchorsuch that the pliable member unfolds and such that the inner shaft isremoved from the bone hole and the anchor and the suture remain in thebone hole.

The method can have any number of variations. For example, a first endof the pliable member can be fixedly attached to the inner shaft and cannot be movable relative to the inner shaft, a second end of the pliablemember can be freely movable relative to the inner shaft, the second endof the pliable member can automatically move relative to the inner shaftin response to the axial and proximal translation of the inner shaft tounfold the pliable member, and the movement of the pliable member cancause the enclosed passage to be opened.

For another example, a first end of the pliable member can be fixedlyattached to a handle of the inserter tool and not be movable relative tothe inner shaft, and a second end of the pliable member can be freelymovable relative to the inner shaft, the second end of the pliablemember can automatically move relative to the inner shaft in response tothe axial and proximal translation of the inner shaft to unfold thepliable member, and the movement of the pliable member can cause theenclosed passage to be opened.

For another example, the method can include, before the movement of theouter shaft axially and distally, tensioning the suture. For yet anotherexample, the method can include retaining the suture in a sutureretention member at a handle of the inserter tool. For still anotherexample, the method can include, before the movement of the outer shaftaxially and distally, moving a locking mechanism from a locked position,in which the outer shaft is prevented from translating axially anddistally relative to the inner shaft, to an unlocked position, in whichthe outer shaft is allowed to translate axially and distally relative tothe inner shaft. For another example, the pliable member can be madefrom a shape memory or superelastic material.

For yet another example, striking a strike cap of the inserter tool cancause the movement of the outer shaft axially and distally. The methodcan include, before striking the strike cap, moving a locking mechanismfrom a locked position, in which the outer shaft is prevented fromtranslating axially and distally relative to the inner shaft, to anunlocked position, in which the outer shaft is allowed to translateaxially and distally relative to the inner shaft. The method caninclude, before striking the strike cap, moving a protective member froma closed position, in which the protective member covers a strikesurface of the strike cap, to an open position, in which the protectivemember does not cover a strike surface of the strike cap.

For another example, the method can include, before positioning thedistal end of the inner shaft in the bone hole, loading the suture intothe enclosed passage using a suture threader.

In another embodiment, a surgical method includes positioning a distalend of an inner shaft of an inserter tool in a bone hole. The distal endof the inner shaft has a notch formed therein, a suture is seated in thenotch, and the inner shaft extends through a cannulated tapered anchorthat has a plurality of bone-engaging surface features extendinghelically along a length of the anchor. The method also includes movingan outer shaft of the inserter tool axially and distally relative to theinner shaft, thereby causing the anchor to slide along the inner shaftand be positioned in the bone hole such that the anchor traps the suturebetween an exterior surface of the anchor and a wall of the bone hole.

The method can vary in any number of ways. For example, the anchor cantaper radially inward in a distal direction such that a diameter of thetapered helical anchor at a proximal end of the anchor is greater than adiameter of the anchor at a distal end of the anchor. With the anchorpositioned in the bone hole, the proximal end of the anchor can engagecortical bone and the distal end of the anchor can engage cancellousbone.

For another example, the method can include, after the movement of theouter shaft axially and distally, moving the outer and inner shaftsaxially and proximally relative to the anchor such that the inner shaftis removed from the bone hole and the anchor and the suture remain inthe bone hole. For yet another example, the bone-engaging surfacefeatures can be threads.

BRIEF DESCRIPTION OF DRAWINGS

The present invention is described by way of reference to theaccompanying figures which are as follows:

FIG. 1 is a perspective view of one embodiment of an inserter tool andone embodiment of a locking aid coupled to the inserter tool;

FIG. 2 is a perspective view of a distal portion of the inserter tool ofFIG. 1 without the loading aid coupled thereto and with one embodimentof a suture coupled to the inserter tool;

FIG. 3 is a side, partial cross-sectional view of the suture and adistal portion of the inserter tool of FIG. 2 ;

FIG. 4 is a perspective view of a distal portion of the inserter tool ofFIG. 1 with the suture of FIG. 2 not yet coupled to the inserter tool;

FIG. 5 is a perspective view of a distal portion of the inserter tool ofFIG. 4 with the suture positioned in a distal seating groove of theloading aid;

FIG. 6 is another perspective view of the inserter tool, the loadingaid, and the suture of FIG. 5 ,

FIG. 7 is a perspective view of a distal portion of the inserter tool ofFIGS. 5 and 6 with the suture positioned in a loading channel of theloading aid;

FIG. 8 is another perspective view of the inserter tool, the loadingaid, and the suture of FIG. 7 ;

FIG. 9 is a perspective view of a distal portion of the inserter tool ofFIGS. 7 and 8 with the suture positioned in a release channel of theloading aid and in a suture retention channel of the inserter tool;

FIG. 10 is a perspective view of a distal portion of the inserter toolof FIG. 9 with the loading aid being removed from the inserter tool andthe suture;

FIG. 11 is a side, partial cross-sectional view of the suture of FIG. 2and a distal portion of another embodiment of an inserter tool;

FIG. 12 is a side, partial cross-sectional view of the suture of FIG. 2and a distal portion of yet another embodiment of an inserter tool;

FIG. 13 is a side, partial cross-sectional view of the suture of FIG. 12and a distal portion the inserter tool of FIG. 12 with the loading aidof FIG. 1 coupled thereto;

FIG. 14 is a perspective view of another embodiment of a loading aidcoupled to the inserter tool of FIG. 1 ;

FIG. 15 is a perspective view of the loading aid and the inserter toolof FIG. 14 with a suture seated in a distal seating groove of theloading aid;

FIG. 16 is a perspective view of the loading aid and the inserter toolof FIG. 15 with the suture positioned in a release channel of theloading aid and in the suture retention channel of the inserter tool;

FIG. 17 is a perspective view of still another embodiment of an insertertool;

FIG. 18 is a side view of a distal portion of the inserter tool of FIG.17 ;

FIG. 19 is a side view of a distal portion of the inserter tool of FIG.17 , another embodiment of a suture, and another embodiment of a loadingaid;

FIG. 20 is a side view of a distal portion of the inserter tool, theloading aid, and the suture of FIG. 19 with the suture positioned in aloop of the inserter tool and in an enclosed passage of the loading aid;

FIG. 21 is a side view of a distal portion of the inserter tool and thesuture of FIG. 20 with the suture positioned in a loop of the insertertool and with the loading aid removed;

FIG. 22 is a side view of a distal portion of the inserter tool and thesuture of FIG. 21 with the loop opened;

FIG. 23 is a side cross-sectional view of a proximal portion of anotherembodiment of an inserter tool;

FIG. 24 is a perspective, partially transparent view of a distal portionof yet another embodiment of an inserter tool;

FIG. 25 is a side, partially cross-sectional view of a distal portion ofthe inserter tool of FIG. 24 ;

FIG. 26 is a side, partially cross-sectional view of a distal portion ofthe inserter tool of FIG. 25 with an anchor distally advanced therefrom;

FIG. 27 is a perspective view of a distal portion of still anotherembodiment of an inserter tool;

FIG. 28 is a perspective view of distal portion of inner and outershafts of the inserter tool of FIG. 27 ;

FIG. 29 is a perspective view of distal portion of the inserter tool ofFIG. 27 with another embodiment of a suture coupled thereto;

FIG. 30 is a side view of an anchor and a distal cap implanted in boneusing the inserter tool of FIG. 27 ;

FIG. 31 is a perspective view of a distal portion of the inserter toolof FIG. 27 coupled to another embodiment of a loading aid and anotherembodiment of a suture seated in a distal seating groove of the loadingaid;

FIG. 32 is a perspective view of the loading aid, the suture, and adistal portion of the inserter tool of FIG. 31 with the suture seated ina notch of the inserter tool;

FIG. 33 is a perspective view of the loading aid, the suture, and adistal portion of the inserter tool of FIG. 32 with a distal cap coupledto the inserter tool;

FIG. 34 is a perspective view of a proximal portion of anotherembodiment of an inserter tool;

FIG. 35 is a perspective view of an intermediate portion of the insertertool of FIG. 34 ;

FIG. 36 is a cross-sectional view of the inserter tool of FIG. 34 ;

FIG. 37 is a perspective view of a distal portion of the inserter toolof FIG. 34 with a suture coupled thereto and with the suture extendingthrough one embodiment of a cannula positioned in a patient;

FIG. 38 is a perspective view of a proximal portion of yet anotherembodiment of an inserter tool with a protective member in a closedposition;

FIG. 39 is another perspective view of a proximal portion of theinserter tool of FIG. 38 ;

FIG. 40 is a perspective view of a proximal portion of the inserter toolof FIG. 38 with the protective member in an open position;

FIG. 41 is another perspective view of a proximal portion of theinserter tool of FIG. 40 and of one embodiment of a mallet;

FIG. 42 is a perspective view of a still another embodiment of aninserter tool;

FIG. 43 is a cross-sectional view of a portion of the inserter tool ofFIG. 42 ;

FIG. 44 is a perspective view of a distal portion of the inserter toolof FIG. 42 ;

FIG. 45 is a perspective view of a distal portion of the inserter toolof FIG. 44 with an inner shaft of the inserter tool advanced fartherdistally relative to an outer shaft of the inserter tool;

FIG. 46 is a perspective view of a proximal portion of the inserter toolof FIG. 42 ;

FIG. 47 is another perspective view of a distal portion of the insertertool of FIG. 45 with an anchor advanced distally relative to the innerand outer shafts;

FIG. 48 is a cross-sectional view of the anchor and the inner and outershafts of the inserter tool of FIG. 42 ;

FIG. 49 is a perspective view of a still another embodiment of aninserter tool;

FIG. 50 is a perspective view of a distal portion of the inserter toolof FIG. 49 ;

FIG. 51 is another perspective view of a distal portion of the insertertool of FIG. 49 ;

FIG. 51A is a perspective view of an embodiment of an anchor;

FIG. 52 is a cross-sectional view of a distal portion of the insertertool of FIG. 49 ;

FIG. 53 is yet another perspective view of a distal portion of theinserter tool of FIG. 49 ;

FIG. 54 is a perspective view of a proximal portion of the inserter toolof FIG. 49 with a locking mechanism of the inserter tool in an unlockedposition before striking of a strike cap of the inserter tool;

FIG. 55 is a perspective view of a proximal portion of the inserter toolof FIG. 49 with the locking mechanism of the inserter tool in a lockedposition;

FIG. 56 is a perspective view of a proximal portion of the inserter toolof FIG. 50 after striking of the strike cap;

FIG. 57 is another perspective view of the inserter tool of FIG. 49 withthe locking mechanism of the inserter tool in a locked position and withanother embodiment of a loading aid coupled to the inserter tool;

FIG. 58 is another perspective view of the inserter tool and the loadingaid of FIG. 57 ;

FIG. 59 is a cross-sectional view of the inserter tool of FIG. 52 and asuture extending through an enclosed passage of the inserter tool;

FIG. 60 is a cross-sectional view of the inserter tool of FIG. 59showing a distal force being applied to an anchor of the inserter tool;

FIG. 61 is a cross-sectional view of the inserter tool of FIG. 60showing the distal force continued to be applied to the anchor;

FIG. 62 is a perspective view of the inserter tool of FIG. 61 showingthe anchor fully distally advanced after striking of the strike cap ofthe inserter tool;

FIG. 63 is a cross-sectional view of the inserter tool of FIG. 62showing a proximal force being applied to the inserter tool;

FIG. 64 is a cross-sectional view of the inserter tool of FIG. 63showing the proximal force continued to be applied to the inserter tool;

FIG. 65 is a cross-sectional view of the inserter tool of FIG. 64showing the proximal force continued to be applied to the inserter tool;

FIG. 66 is a cross-sectional view of a distal portion of anotherembodiment of an inserter tool;

FIG. 67 is a cross-sectional view of a distal portion of an inner shaftof the inserter tool of FIG. 66 ;

FIG. 68 is a cross-sectional view of the inserter tool of FIG. 66 ;

FIG. 69 is a cross-sectional view of a proximal portion of the insertertool of FIG. 66 after actuation of an actuator of the inserter tool;

FIG. 70 is a perspective view of a distal portion of yet anotherembodiment of an inserter tool;

FIG. 71 is a perspective view of the distal portion the inserter tool ofFIG. 70 after actuation of an actuator of the inserter tool;

FIG. 72 is a perspective view of still another embodiment of an insertertool;

FIG. 73 is another perspective view of the inserter tool of FIG. 72 witha locking mechanism of the inserter tool in a locked position and withthe loading aid of FIG. 57 coupled to the inserter tool;

FIG. 74 is another perspective view of the inserter tool and the loadingaid of FIG. 73 ;

FIG. 75 is a perspective view of the inserter tool of FIG. 72 afterstriking of a strike cap of the inserter tool;

FIG. 76 is a perspective view of an intermediate portion of the insertertool of FIG. 72 ;

FIG. 77 is another perspective view of the intermediate portion of theinserter tool of FIG. 76 ;

FIG. 78 is a perspective view of the intermediate portion of theinserter tool of FIG. 77 with a suture retained by a suture retentionchannel of the inserter tool;

FIG. 79 is another perspective view of an intermediate portion of theinserter tool of FIG. 72 ;

FIG. 80 is a perspective view of one embodiment of a tapered helicalanchor;

FIG. 81 is an end view of the anchor of FIG. 80 ;

FIG. 82 is a perspective view of another embodiment of a tapered helicalanchor;

FIG. 83 is an end view of the anchor of FIG. 82 ;

FIG. 84 is a perspective view of yet another embodiment of a taperedhelical anchor;

FIG. 85 is an end view of the anchor of FIG. 84 ;

FIG. 86 is a perspective view of still another embodiment of a taperedhelical anchor;

FIG. 87 is an end view of the anchor of FIG. 86 ;

FIG. 88 is a perspective view of another embodiment of a tapered helicalanchor;

FIG. 89 is an end view of the anchor of FIG. 88 ;

FIG. 90 is a side view of still another embodiment of a tapered helicalanchor;

FIG. 91 is an end view of the anchor of FIG. 90 ;

FIG. 92 is a side view of yet another embodiment of a tapered helicalanchor;

FIG. 93 is a perspective view of the anchor of FIG. 92 releasablycoupled to the inserter tool of FIG. 1 ; and

FIG. 94 is another perspective view of the anchor of FIG. 92 releasablycoupled to the inserter tool of FIG. 1 .

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices, systems, and methods disclosedherein. One or more examples of these embodiments are illustrated in theaccompanying drawings. A person skilled in the art will understand thatthe devices, systems, and methods specifically described herein andillustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Further, in the present disclosure, like-named components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-named component is notnecessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. A person skilled inthe art will appreciate that a dimension may not be a precise value butnevertheless be considered to be at about that value due to any numberof factors such as manufacturing tolerances and sensitivity ofmeasurement equipment. Sizes and shapes of the systems and devices, andthe components thereof, can depend at least on the anatomy of thesubject in which the systems and devices will be used, the size andshape of components with which the systems and devices will be used, andthe methods and procedures in which the systems and devices will beused.

Various exemplary systems and devices for knotless anchor insertion andmethods of knotless anchor insertion are provided. In general, aninserter tool is configured for knotless anchor insertion in a softtissue repair surgical procedure. The inserter tool is configured toinsert an anchor into a bone of a patient to secure a soft tissuerelative to the bone. A suture coupled to the soft tissue is securedrelative to the bone by being trapped between an exterior surface of theanchor and a bone surface defining a hole in the bone in which theanchor is positioned. The anchor therefore allows the suture to besecured in position without needing to be knotted, which can be timeconsuming and/or difficult to perform during surgery because of smallsuture diameter, limited working area at a joint space, a wet surgicalenvironment, and/or limited visualization at the surgical site due tochallenging angles and the tight nature of the joint space.

The inserter tool is configured to have each of the suture and theanchor releasably coupled thereto and, with the suture and the anchorreleasably coupled thereto, to insert each of the suture and the anchorinto the bone hole. The inserter tool is configured to position thesuture in the bone hole before the anchor is secured in the bone hole.The inserter tool is thus configured to allow the suture to be tensionedrelative to the bone and the anchor after the suture has been positionedin the bone hole and before the anchor is secured in the bone hole tofix the suture in position relative to the bone, thereby allowing thesoft tissue to be desirably positioned relative to the bone before beingsecured in position for healing. The inserter tool is configured toadvance the anchor into the bone hole by longitudinally translating theanchor in a distal direction into the bone hole, such as by hitting theinserter tool with a mallet, hammer, or other tool, thereby trapping thesuture between the exterior surface of the anchor and the bone surfacedefining the bone hole. After the anchor has been inserted into thebone, the inserter tool is configured to be longitudinally translated ina proximal direction to be removed from the patient's body with theanchor and the suture remaining in the bone. Decoupling the insertertool from the suture and the anchor by longitudinally translating theinserter tool along its longitudinal axis may be less time consumingand/or may require less user-applied force than other methods ofdecoupling a tool from an implanted anchor that include rotating thetool about its longitudinal axis. Unlike longitudinally translating theinserter tool for removal, rotating the tool for removal can riskrotating the anchor and/or unintended off axis loading, which can causethe anchor to become less securely positioned in the bone and/or cancause damage to the suture and/or to the anchor.

The suture is releasably coupled to the inserter tool before theinserter tool is advanced into the patient's body. In at least someembodiments, a loading aid is configured to facilitate coupling of thesuture and the inserter tool. In general, the loading aid is configuredto position the suture in a suture retention channel of the insertertool. The suture is configured to be slid into the suture retentionchannel and snap-fit therein using the loading aid. The suture thus neednot be fed by a user through an aperture, eyelet, or other opening ofthe anchor or the inserter tool to be coupled to the inserter tool forinsertion into the patient's body. Feeding a suture through an aperture,eyelet, or other opening can, similar to the threading of a needle, betime consuming and/or difficult to perform because of small suturediameter, small opening diameter, and/or a wet surgical environment. Theloading aid is configured to properly align the suture with the sutureretention channel to facilitate the sliding of the suture into thesuture retention channel, which relieves a user of having to align thesuture and suture retention channel by direct eye visualization orelectronic visualization, which may be time consuming and/or difficultto perform because of small suture diameter, small opening diameter,and/or a wet surgical environment.

The suture retention channel is located distal to the anchor releasablycoupled to the inserter tool. The suture seated in the suture retentionchannel can thus be positioned in the bone hole distal to the anchor,thereby allowing the anchor to be advanced distally into the bone holewith the suture already positioned in the bone hole. In an exemplaryembodiment, the suture has a U-shape before and after the anchor isfixed in the bone hole. In the U-shape, each of the suture's legs extendlongitudinally along opposed sides of the anchor, and an intermediateportion of the suture that connects the legs extends along the anchor'sdistal tip so as to loop around the anchor's distal tip. The U-shapeconfiguration of the suture relative to the anchor may maximize a lengthof the suture that the anchor presses against to fix the suture inposition relative to the bone, which may help ensure that the softtissue coupled to the suture remains in a fixed position relative to thebone to facilitate healing.

The systems, devices, and methods described herein have applicability ina variety of surgical procedures for soft tissue repair, such as in atissue repair surgical procedure at a joint such as a shoulder, a knee,or a hip.

FIG. 1 illustrates one embodiment of an inserter tool 100, also referredto herein as an “inserter,” for knotless anchor insertion in a softtissue repair surgical procedure. In general, the inserter tool 100 isconfigured to insert an anchor 102 into a bone of a patient to secure asoft tissue relative to the bone. As shown in FIG. 2 , an inner lumen102 i extends through the anchor 102 such that the anchor 102 iscannulated. A plurality of bone-engaging surface features 102 f areformed on an exterior surface of the anchor 102. The bone-engagingsurface features 102 f are configured to engage bone to retain theanchor 102 in the bone, e.g., to engage a surface of bone defining thebone hole in which the anchor 102 is positioned. The bone-engagingsurface features 102 f include a plurality of ribs each extendingcircumferentially around the anchor 102 at different axial positionsalong the anchor's longitudinal length. The bone-engaging surfacefeatures 102 f can, however, have another configuration, such as aplurality of barbs or other form of protrusions formed on the anchor'sexterior surface. The bone-engaging surface features 102 f are alsoconfigured to engage a suture against the bone to help secure the suturerelative to the bone.

The anchor 102 can be absorbable or non-absorbable. The anchor 102 canbe made from any of a variety of materials, e.g., Polyether ether ketone(PEEK), Polylactic acid or polylactide (PLA), BIOCRYL®, BIOCRYL®RAPIDE®, titanium, ceramics, carbon fiber, stainless steel, etc. Theanchor 102 can be formed by a variety of techniques, for example bymachining, molding, metal injection molding, overmolding, or by apost-molding process such as post-molding machining. Exemplaryembodiments of anchors include the Healix Advance™ anchors and theGryphon® anchor available from DePuy Mitek, Inc. of Raynham, MA, andvarious exemplary embodiments of anchors and features thereof arefurther described in U.S. Pat. No. 8,114,128 entitled “Cannulated SutureAnchor” issued Feb. 14, 2012, U.S. Pat. No. 8,882,801 entitled “DualThread Cannulated Suture Anchor” issued Nov. 11, 2014, and U.S. Pat. No.8,133,257 entitled “Bioabsorbable Suture Anchor System For Use In SmallJoints” issued Mar. 13, 2012, which are hereby incorporated by referencein their entireties.

The inserter tool 100 includes a handle 106, an outer shaft 108 thatextends distally from the handle 106, an inner shaft 110 that extendsdistally from the handle 106, and a strike cap 112 that extendsproximally from the handle 106. The handle 106 is configured to be heldby hand during use of the inserter 100. In robotic surgicalimplementations, the handle 106 can be held by a mechanical member ofthe robotic surgical system. The handle 106 has a generally cylindrical,distally-tapering shape in this illustrated embodiment but can have anyof a variety of shapes. The handle 106 has an inner lumen 106 iextending therethrough. The outer and inner shafts 108, 110 arepositioned in the inner lumen 106 i extend distally out of the innerlumen 106 i. Proximal ends of one or both of the outer and inner shafts108, 110 can be located within the inner lumen 106, or one or both ofthe outer and inner shafts 108, 110 can extend proximally beyond thehandle 106 such that the respective proximal ends of the outer and innershafts 108, 110 are located proximal to the handle 106. For example, asin this illustrated embodiment, the proximal end of the inner shaft 110can be attached to the handle 106, and the proximal end of the outershaft 108, also referred to herein as a “push tube,” can be locatedwithin the inner lumen 106 i of the handle 106. For another example, theproximal end of the inner shaft 110 can be attached to the handle 106,and the proximal end of the outer shaft 108 can be located proximal tothe handle 106.

A distal end of the strike cap 112 abuts the proximal end of the pushtube 108 in the inserter's initial configuration, which may maximizetransmission of a distal force applied to the strike cap 112 to the pushtube 108 and thereby help efficiently distally advance the push tube 108to distally advance the anchor 102 into the bone hole. However, thestrike cap's distal end can be spaced a distance proximal to the pushtube's proximal end, or the strike cap 112 can be integrally formed withthe push tube 108. The strike cap 112 is configured to be struck with amallet, hammer, or other tool on a proximal surface 11 s thereof. Theproximal surface 112 s is substantially flat in this illustratedembodiment, which may facilitate an even strike on the strike cap 112and thus an evenly transmitted distal force from the strike cap 112 tothe push tube 108. A person skilled in the art will appreciate that asurface may not be precisely flat but nevertheless considered to besubstantially flat for any of one or more reasons, such as manufacturingtolerances or sensitivity of measurement equipment. The proximal surface112 s can however, have another shape, e.g., textured with ribs, raiseddome protrusions, etc.; convex; etc.

An inner lumen 108 i extends through the outer shaft 108 such that theouter shaft 108 is cannulated. In an initial configuration of theinserter 100, which is shown in FIGS. 1 and 2 , the inner shaft 110 isseated in the inner lumen 102 i of the anchor 102 and in the inner lumen108 i of the outer shaft 108. FIG. 2 shows a portion of the outer shaft108 removed and without the inner shaft 110 therein for clarity ofillustrating the outer shaft's tubular configuration in at least thisportion of the outer shaft 108. The inner shaft 110 extends distallyfrom the outer shaft 108 and from the anchor 102. A distal end 108 d ofthe outer shaft 108 is located proximal to a proximal end 102 p of theanchor 102. In an exemplary embodiment, as shown in FIGS. 1 and 2 , theouter shaft's distal end 108 d abuts the anchor's proximal end 102 p inthe inserter's initial configuration, which may maximize transmission ofa distal force applied to the push tube 108 to the anchor 102 andthereby help efficiently distally advance the anchor 102 into the bonehole. However, the outer shaft's distal end 108 d can be spaced adistance proximal to the anchor's proximal end 102 p in the inserter'sinitial configuration.

As in this illustrated embodiment, a locking mechanism 118 can beconfigured to be releasably coupled to the inserter tool 100. Thelocking mechanism 118 is configured to lock the outer shaft 108 inposition relative to the inner shaft 110 when the locking mechanism 118is coupled to the inserter tool 100. The locking mechanism 118 maytherefore help prevent premature distal advancement of the outer shaft108 relative to the inner shaft 110 and thus help prevent prematuredistal advancement of the anchor 102 relative to the inner shaft 110.The locking mechanism 118 in this illustrated embodiment includes a clipthat includes a pair of resilient legs 118 g. The resilient legs 118 ghave a size and shape that allows the legs 118 g to seat a distalextension of the strike cap 112 therebetween and to be positionedbetween a proximal surface of the handle 106 and a distal surface of thestrike cap 112. The locking mechanism 118 coupled to the inserter tool100 therefore prevents the strike cap 112 from moving distally relativeto the handle 106 and thus also prevents a strike on the strike cap 112from pushing the push tube 108 distally until the locking mechanism 118is removed from the inserter tool 100. The locking mechanism 118 isconfigured to be removed from the inserter tool 100 by gripping a handleportion 118 h of the locking mechanism 118 and pulling the lockingmechanism 118 away from the inserter 100, which causes the resilientlegs 118 g to flex radially outward and release the strike cap 112therefrom.

As shown in FIG. 2 , with the inserter 100 in the initial configuration,a suture 114 releasably coupled to the inserter 100 has a U-shape. Asdiscussed above, the suture 114 having the U-shape before anchor 102insertion into the bone hole allows for the suture 114, after anchor 102insertion into the bone hole, to have each of the suture's two legs 114g extending longitudinally along opposed sides of the anchor 102, and anintermediate portion 114 i of the suture 114 that connects the legs 114g extending along the anchor's distal tip 102 t so as to loop around theanchor's distal tip 102 t. As also shown in FIG. 3 , the suture 114includes two suture strands in this illustrated embodiment but caninclude another number of suture strands, e.g., one, three, four, etc.

As shown in FIGS. 2 and 3 , the inner shaft 110 includes a notch formedtherein that defines a suture retention channel 116. The notch is formedin a distal end of the inner shaft 110 and is defined by opposed distalarms 120 of the inner shaft 110. A proximal portion 116 p of the sutureretention channel 116 is configured to seat the suture 114 therein. Theproximal portion 116 p of the suture retention channel 116 has an opendistal end and a closed proximal end that defines the suture retentionchannel's proximal end. A distal portion 116 d of the suture retentionchannel 116 extends distally from the proximal portion 116 p of thesuture retention channel 116. The distal portion 116 d of the sutureretention channel 116 has an open proximal end and has an open distalend that defines the suture retention channel's distal end. The sutureretention channel 116 thus has a closed proximal end and an open distalend. The suture retention channel 116 is configured to receive thesuture 114 therein through the suture retention channel's open distalend. The suture 114 can then move through the distal portion 116 d ofthe suture retention channel 116 to be positioned in the proximalportion 116 p of the suture retention channel 116. The proximal portion116 p of the suture retention channel 116 has a diameter D1 that isgreater than a diameter D2 of the distal portion 116 d of the sutureretention channel 116, which may help retain the suture 114 in thesuture retention channel 116 by discouraging, if not preventing, thesuture 114 from moving distally out of the suture retention channel 116before a desired time of suture 114 decoupling from the inserter tool100.

The distal arms 120 of the inner shaft 110 are configured to spring backand forth relative to one another, similar to tweezer arms. The movementof the distal arms 120 relative to one another is configured to changethe diameter D2 of the distal portion 116 d of the suture retentionchannel 116 to facilitate seating of the suture 114 in the sutureretention channel 116 and removal of the suture 114 from the sutureretention channel 116. FIGS. 2 and 3 show the arms 120 in a restingconfiguration in which the diameter D2 of the distal portion 116 d ofthe suture retention channel 116 is at a minimum. The arms 120 areconfigured to move from the resting configuration to an expandedconfiguration in which the arms 120 are moved radially outward such thatthe suture retention channel 116 becomes larger with the diameter D2 ofthe distal portion 116 d of the suture retention channel 116 increasingfrom the diameter D1 in a least a distal portion of the suture retentionchannel's distal portion 116 d. The expanded diameter D2 of the distalportion 116 d provides more space for the suture 114 to enter into thesuture retention channel 116. The arms 120 are biased to the restingconfiguration such that the arms 120 are configured to dynamically movefrom the resting configuration to the expanded configuration in responseto the suture 114 being advanced proximally into the suture retentionchannel 116, such that the arms 120 are configured to dynamically movefrom the expanded configuration to the resting configuration in responseto the suture 114 being advanced proximally out of the distal portion116 d and into the proximal portion 116 p of the suture retentionchannel 116, and such that arms 120 are configured to dynamically movefrom the resting configuration to the expanded configuration in responseto the suture 114 being advanced distally out of the proximal portion116 p into the distal portion 116 d and then out of the suture retentionchannel 116.

The suture retention channel 116 may allow for more sutures and/orlarger diameter suture(s) to be coupled to the inserter 100 than withother types of inserter tools since the suture(s) do not need to befolded over to be inserted into an aperture, eyelet, or other opening tobe coupled to the inserter tool or to the anchor.

As shown in FIGS. 1 and 2 , the suture retention channel 116 is locateddistal to the anchor 102 releasably coupled to the inserter tool 100.The suture 114 seated in the suture retention channel 116 can thus bepositioned in the bone hole distal to the anchor 102, thereby allowingthe anchor 102 to be advanced distally into the bone hole with thesuture already positioned in the bone hole.

The suture 114 is positioned in the suture retention channel 116 by auser of the inserter tool 100, which may provide a user of the inserter100 flexibility in deciding on a size and type of suture 114 to use thatis appropriate for a particular patient and a particular surgicalprocedure. The suture 114 can be positioned in the suture retentionchannel 116 by the user by hand, similar to the threading of a needle.Alternatively to hand positioning, the suture 114 can be positioned inthe suture retention channel 116 using a tool such as a pusher tube or aloading aid. One embodiment of a loading aid 122 is illustrated in FIGS.1 and 4 .

A distal portion of the inner shaft 110 including the arms 120 can bemade from a shape memory or superelastic material, such as Nitinol orother material, which may facilitate movement of the arms 120 betweenthe resting configuration and the expanded configuration. The restingconfiguration can be the default shape of the arms 120. In someembodiments, the only portion of the inner shaft 110 made from a shapememory or superelastic material can include the arms 120. In otherembodiments, only a distal portion of the inner shaft 110 that extendsdistally from the outer shaft 108 can be made from a shape memory orsuperelastic material. In other embodiments, only a distal portion ofthe inner shaft 110 that extends distally to the anchor 102 an be madefrom a shape memory or superelastic material.

FIGS. 1 and 4 illustrate the loading aid 122 positioned relative to theinserter tool 100 before the suture 114 is positioned in the sutureretention channel 116. The loading aid 122 is positioned over a distalend of the inserter tool 100 and in particular over a distal end of theinner shaft 110. The loading aid 122 is directly coupled to the innershaft 110 in this illustrated embodiment but can be indirectly coupledto the inner shaft 110, such as by being directly coupled to anotherpart of the inserter 100 such as the outer shaft 108 or directly coupledto the anchor 102 that has the inner shaft 110 seated in the inner lumen102 i of the anchor 102. In an exemplary embodiment, the loading aid 122is pre-loaded on the inserter tool 100 during manufacturing, which mayhelp ensure that the loading aid 122 is positioned correctly on theinserter 100 and/or may provide a reminder to a user of the inserter 100that the suture 114 should be coupled to the inserter 100 before theinserter 100 is advanced into a patient's body. Alternatively, theloading aid 122 can be loaded onto the inserter tool 100 by a user,which may allow for the inserter 100 to be sold without the loading aid122 and thus at a lower cost than the inserter 100 sold with the loadingaid 122.

As shown in FIG. 5 , the suture 114 is positioned within a distalseating groove 124 of the loading aid 122. The distal seating groove 124is defined by opposed distal wings 126 of the loading aid 122. Thedistal wings 126 each extend radially outward so as to define a V-shape.The distal seating groove 124 is thus V-shaped. The distal seatinggroove 124 is located distal to the inner shaft's suture retentionchannel 116. The suture 114 is then, as shown in FIG. 6 , positioned onan inner surface 126 s of one of the distal wings 126 and slidproximally along the distal wing's inner surface 126 s to guide thesuture 114 to an apex of the distal seating groove 124, e.g., to thepoint of the V-shape. The suture 114 can be slid along either of thedistal wing's inner surface 126 s. The suture 114 continues to be slidproximally to enter a longitudinal loading channel 128 of the loadingaid 122. The loading channel 128 is aligned with the suture retentionchannel 116. Thus, sliding of the suture 114 within the loading channel128 in a proximal direction causes the suture 114 to enter the sutureretention channel 116 and, in particular, the distal portion 116 dthereof. Continued movement of the suture 114 in a proximal directionwithin the loading channel 128 and the suture retention channel 116causes the suture 114 to be seated in the proximal portion 116 p of thesuture retention channel 116, as shown in FIGS. 7-9 . The closedproximal end of the suture retention channel 116 acts as a stop surfacefor the suture 114 in the suture retention channel 116, although in someembodiments the suture 114 may be positioned in the proximal portion 116p but not abut the stop surface. As discussed above, the distal arms 118of the inner shaft 110 can be splayed radially outward as the suture 114passes into and through the distal portion 116 d and can splay radiallyinward to their resting position after the suture 114 exits the distalportion 116 d and enters the proximal portion 116 p.

As shown in FIG. 9 , the loading aid 122 includes a longitudinal releasechannel 130 located on an opposite side of the loading aid 122 from thelongitudinal loading channel 128. The suture 114 also enters the releasechannel 130 when the suture 114 is slid proximally to enter the loadingchannel 128. The suture 114 also moves proximally in the release channel130 when the suture 114 is slid further proximally in the loadingchannel 128 to enter the proximal portion 116 p of the suture retentionchannel 116. The release channel 130 is configured to facilitate releaseof the loading aid 122 from the inserter tool 100. As shown in FIG. 10 ,lateral movement of the loading aid 122 relative to the inserter 100 (orvice versa) causes the inserter 100, e.g., the inner shaft 110 thereof,to move through the release channel 130 so as to release the loading aid122 from the inserter 100. The suture 114 also moves through the releasechannel 130 during the loading aid's removal from the inserter 100.FIGS. 2 and 3 illustrate the inserter 100 with the loading aid 122removed from the inserter 100 and with the suture 114 positioned in thesuture retention channel 116.

Sliding the suture 114 along the distal wing's inner surface 126 stoward the loading channel 128 may help ensure that the suture 114properly enters the loading channel 128 and thus that the suture 114properly enters the suture retention channel 116, but the suture 114need not slide along either distal wing's inner surface 126 s beforeentering the loading channel 128.

Instead of the suture 114 sliding relative to the loading aid 122 withthe loading aid 122 held in position by hand, the suture 114 can be heldby hand with the loading aid 122 being moved relative thereto to causethe suture 114 to be positioned as described above. In an exemplaryembodiment, the loading aid 122 is held in position by hand and thesuture 114 moved relative thereto. The loading aid 122 includes opposedfinger holds 132 configured to provide a surface easily held by handduring use of the loading aid 122. By including finger holds 132 onopposed sides of the loading aid 122, the loading aid 122 may beconveniently held by a left hand or a right hand and be in an easilyheld position regardless of the loading aid's rotational positionrelative to the user. One of both of the finger holds 132 may be held ata time.

With the suture 114 coupled to the inserter 100, and with the loadingaid 122 removed from the inserter 100 if the loading aid 122 was coupledto the inserter 100 to facilitate suture coupling thereto, the inserter100 can be used to insert the suture 114 and the anchor 102 into a bonehole. In an exemplary embodiment of using the inserter 100 to insert thesuture 114 and the anchor 102 into a bone hole, a drill or other boneremoval tool is inserted into a patient's body to form the bone hole, aswill be appreciated by a person skilled in the art. The drill or otherbone removal tool can be advanced into the patient's body, and thenremoved from the patient's body, through a cannula positioned within anopening, e.g., an incision, formed in the patient's skin, as will alsobe appreciated by a person skilled in the art. The cannula can thenserve as a guide for the inserter's distal advancement toward the bonehole.

The inserter 100 is advanced distally into the body of the patient andpositioned with the distal end of the inner shaft 110 within the bonehole. The suture 114 is thus positioned in the bone hole before theanchor 102 is secured in the bone hole. A bottom surface of the bonehole can act as a stop surface that stops distal movement of theinserter 100 relative to the bone. An interior of the bone hole cannotbe visualized with the inserter 100 positioned in the bone hole, so thebottom surface of the bone hole acting as a stop can help ensure thatthe inserter 100 has been advanced as far as distally possible withinthe bone hole, which may help ensure that the anchor 102 is secured inthe bone hole with the anchor's proximal end flush or sub-flush with aproximal end of the bone hole. Alternatively, the inserter 100 can beinserted into the bone hole only a specified distance prior to a distalend of the anchor 102 engaging an open proximal end of the bone hole. Asthe anchor 102 is not readily advanced into the bone hole withoutimpacting the strike cap 112, the distance the inserter 100 protrudesfrom the anchor 102 controls the distance that the inserter 100 willadvance into the bone hole.

With the distal end of the inner shaft 110 positioned in the bone hole,and prior to distal advancement of the anchor 102 relative to the innershaft 110, the suture 114 can be tensioned as desired. Alternatively,the suture 114 tension can be approximated prior to placement of theinserter 100 into the bone hole, with the advancement of the inserter100 into the bone hole adding tension approximately equal to a length ofthe inserter's distance protruding from the distal end of the anchor102. A person skilled in the art will appreciate that values may not beprecisely equal but nevertheless considered to be approximately equalfor any of one or more reasons, such as manufacturing tolerances orsensitivity of measurement equipment.

With the distal end of the inner shaft 110 positioned in the bone hole,the locking mechanism 118 is removed from the inserter 100. The outershaft 108 is now free to move relative to the inner shaft 110 inresponse to a strike on the strike cap 112.

With the distal end of the inner shaft 110 positioned in the bone hole,the anchor 102 is advanced distally into the bone hole by longitudinallytranslating the anchor 102 relative to the inner shaft 110 in a distaldirection. In other words, the anchor 102 is pushed axially along thelongitudinal axis 104 of the inserter 100. The strike cap 112 is hitwith a mallet, hammer, or other tool to cause the outer tube 108 to movedistally relative to the inner shaft 110, which causes the anchor 102 tomove distally relative to the inner shaft 110 and advance distally intothe bone hole. The strike cap 112 may be hit one or more times to fullyadvance the anchor 102 into the bone hole. The anchor 102 in the bonehole traps the suture 114, e.g., the legs 114 g thereof, between theexterior surface of the anchor 102 and the bone surface defining thebone hole.

After the anchor 102 has been inserted into the bone hole, the inserter100, including the outer and inner shafts 108, 110, is longitudinallytranslated in a proximal direction, e.g., pulled axially along thelongitudinal axis 104 of the inserter 100, to be removed from thepatient's body with the anchor 102 and the suture 114 remaining in thebone. The suture 114 automatically exits the inner shaft's sutureretention channel 116 in response to the proximal pulling of the innershaft 110 out of the bone hole. Tails of the suture 114 can be trimmedas desired.

FIG. 11 illustrates another embodiment of an inner shaft 200 of aninserter tool. The inner shaft 200 is configured and used similar to theinner shaft 110 of the inserter tool 100 of FIG. 1 except that the innershaft's suture retention channel 202 has a narrower distal portion 202 ddefined by the inner shaft's distal arms 204 as compared to the distalportion 116 p of the suture retention channel 116. In general, thenarrower a distal portion of a suture retention channel, the less likelythat a suture positioned in the suture retention channel willprematurely exit the suture retention channel through the distalportion, e.g., through the open distal end thereof. FIG. 11 shows thesuture 114 positioned in a proximal portion 202 p of the sutureretention channel 202.

FIGS. 12 and 13 illustrates another embodiment of an inner shaft 300 ofan inserter tool. In this illustrated embodiment, the inner shaft 300 isconfigured and used similar to the inner shaft 110 of the inserter tool100 of FIG. 1 except that the inner shaft's suture retention channel 302does not have a longitudinal distal portion like the distal portion 116p of the suture retention channel 116. Instead, the suture retentionchannel's distal portion 302 d is a tortuous channel that follows atortuous path. The tortuous path makes it less likely that a suturepositioned in the suture retention channel 302 will prematurely exit thesuture retention channel 302 through the distal portion 302 d, e.g.,through the open distal end thereof. FIG. 12 shows the suture 114positioned in a proximal portion 302 p of the suture retention channel302. FIG. 13 shows the loading aid 122 coupled to the inner shaft 300 toaid seating of the suture 114 in the suture retention channel 302.

FIGS. 14-16 illustrate another embodiment of a loading aid 400. Theloading aid 400 is shown in FIGS. 14-16 in use with the outer and innershafts 108, 110 of FIG. 1 , with the suture 114 of FIG. 2 , and withanother embodiment of an anchor 402 but can be similarly used with otherouter and inner shafts and other anchors. In this illustratedembodiment, the loading aid 400 is configured and used similar to theloading aid 122 of FIG. 1 except that opposed finger holds 404 of theloading aid 400 extend farther laterally outward than the opposed fingerholds 132 of the loading aid 122. FIG. 14 shows the loading aid 400positioned relative to the inner shaft 110 before the suture 114 ispositioned in the suture retention channel 116. FIG. 15 shows the suture114 positioned in a V-shaped distal seating groove 404 of the loadingaid 400. An arrow 406 in FIG. 15 illustrates a proximal direction ofmovement for the suture 114 to move into the suture retention channel116. FIG. 16 shows the suture 114 seated in the suture retention channel116 and in a longitudinal loading channel 408 of the loading aid 400. Anarrow 410 in FIG. 16 indicates a direction in which the loading aid 400can be moved relative to the inner shaft 116 to remove the loading aid400 therefrom.

FIG. 17 illustrates another embodiment of an inserter tool 500 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 500 is generally configured and used similar to theinserter tool 100 of FIG. 1 , e.g., is configured to insert an anchorinto a bone of a patient to secure a soft tissue relative to the boneand includes a handle 506, an outer shaft 508 that extends distally fromthe handle 506, an inner shaft 510 that extends distally from the handle506, and a strike cap 512 that extends proximally from the handle 506.However, in this illustrated embodiment, the inner shaft 510 does notinclude a notch or suture retention channel. Instead, the inserter tool510 includes a snare configured to seat a suture therein. As shown inFIG. 18 , the snare is defined by a loop 516 of a flexible member 516 f.A “flexible member” is also referred to herein as a “pliable member.”The flexible member 516 f is configured to fold or bend withoutbreaking, cracking, or otherwise losing structural integrity. Theflexible member 516 f is a metal single filament wire in thisillustrated embodiment but can have other configurations, e.g., a metalmulti-filament wire, a braided fabric, a textile strand, a monofilamentfiber, etc. In some embodiments, the flexible member 516 f can be madefrom a shape memory or superelastic material, such as Nitinol or othermaterial.

The loop 516 is located distal to the inner shaft 510 and is thuslocated distal to the anchor 102 that has the inner shaft 510 positionedin the inner lumen 102 i thereof. The loop 516 has a horseshoe shape andhas one end fixedly attached to the inserter 500 and has one end that isfree so as to not be fixedly attached to the inserter 500. The end ofthe flexible member 516 f fixedly attached to the inserter 500 isfixedly attached to an outer shaft 508 of the inserter 500 in thisillustrated embodiment but can be attached to another portion of theinserter 500. The loop 516 defines an enclosed passage 532 incooperation with the distal end of the inner shaft 510. A suture isconfigured to be seated in the loop 516, e.g., extend through thepassage 532, during use of the inserter tool 500, similar to thatdiscussed above regarding the suture retention channel 116 and asdiscussed further below. The free end of the loop 516 can extend throughthe inner shaft 510 and out of the handle 506 to allow a user to tensionthe flexible member 516 f and thereby adjust a size of the passage 532.The handle 506 can include a suture retention member, e.g., a slotformed in the handle 506 and configured to releasably retain the sutureby seating the suture therein in a cinch or pinch, a protrusion aroundwhich the suture can be tied or wrapped, etc., to allow the tension onthe flexible member 516 f to be maintained and thus for the loop 516size to be maintained. Embodiments of suture retention members arediscussed further below.

The anchor 102 shown in FIG. 17 is the same anchor 102 as shown in FIG.1 , but other anchors can be similarly used with the inserter tool 500.

As in this illustrated embodiment, a locking mechanism 518 can beconfigured to be releasably coupled to the inserter tool 500 to lock theouter shaft 508 in position relative to the inner shaft 510 when thelocking mechanism 518 is coupled to the inserter tool 500. The lockingmechanism 518 is generally configured and used similar to the lockingmechanism 118 of FIG. 1 .

The suture is positioned in the loop 516 by a user of the inserter tool500, which may provide a user of the inserter 500 flexibility indeciding on a size and type of suture to use that is appropriate for aparticular patient and a particular surgical procedure. The suture canbe positioned in the loop 516 by the user by hand, similar to thethreading of a needle. Alternatively to hand positioning, the suture canbe positioned in the loop 516 using a loading aid 522, illustrated inFIG. 19 . In embodiments in which the suture is positioned in the loop516 by a user of the inserter tool 500, the user can manually adjust asize of the loop 516 as desired to help position the suture in the loop516 by pulling on the flexible member 516 f, e.g., to move a length ofthe flexible member 516 f out of the inner shaft 510 to increase a sizeof the loop 516, or pushing on the flexible member 516 f, e.g., to movea length of the flexible member 516 f into the inner shaft 510 todecrease a size of the loop 516.

The loading aid 522 in this illustrated embodiment includes a suturethreader. A suture threader can have a variety of configurations, aswill be appreciated by a person skilled in the art. In this illustratedembodiment, the loading aid 522 includes a base 524 and a wire loop 526that is attached to the base 524, that extends distally from the base524, and that defines an enclosed passage 528. The wire loop 526 isformed by a metal single filament wire in this illustrated embodimentbut can have other configurations, similar to the loop 516 discussedabove. A suture 514 is configured to be seated in the passage 528defined by the loop 526, as shown in FIG. 19 . The suture 514 isgenerally configured and used similar to the suture 114 of FIG. 2 and,similar to that discussed above regarding the suture 114, includes twostrands in this illustrated embodiment but can include another number ofstrands. The suture 514 can be coupled to the loading aid 522 by a user,which may provide a user of the inserter 500 flexibility in deciding ona size and type of suture to use that is appropriate for a particularpatient and a particular surgical procedure and/or may allow for theinserter 500 to be sold without the loading aid 522 and thus at a lowercost than the inserter 500 sold with the loading aid 522.

With the suture 514 extending through the loop 526 of the loading aid522, the loading aid 522 can be pulled by the base 524 to pull thesuture 514 through the snare, e.g., through the loop 516 defined by theflexible member 516 f, as shown in FIG. 20 , so as to thread the suture514 through the snare. The suture 514 can then be released from theloading aid 522 by being removed from the passage 528 defined by theloop 526. FIG. 21 illustrates the suture 514 released from the loadingaid 522 and extending through the loop 516 defined by the flexiblemember 516 f. The suture 514 extending through the loop 516 can thus bereleasably coupled to the inserter 500 and have a U-shape with theinserter 500 in its initial configuration, similar to that discussedabove regarding the suture 114 and the inserter 100 of FIG. 2 .

With the suture 514 coupled to the inserter 500, and with the loadingaid 522 removed from the suture 514 if the loading aid 522 was used tofacilitate suture coupling to the inserter 500, the inserter 500 can beused to insert the suture 514 and the anchor 102 into a bone hole. In anexemplary embodiment of using the inserter 500 to insert the suture 514and the anchor 102 into a bone hole, a drill or other bone removal toolis inserted into a patient's body to form the bone hole, similar to thatdiscussed above regarding the inserter 100 of FIG. 1 .

The inserter 500 is advanced distally into the body of the patient andpositioned with the distal end of the inner shaft 510 within the bonehole and thus with the loop 516 within the bone hole. The suture 514that extends through the loop 516 is thus positioned in the bone holebefore the anchor 102 is secured in the bone hole. A bottom surface ofthe bone hole can act as a stop surface that stops distal movement ofthe inserter 500 relative to the bone, similar to that discussed aboveregarding the inserter 100 of FIG. 1 .

With the distal end of the inner shaft 510 positioned in the bone hole,and prior to distal advancement of the anchor 102 relative to the innershaft 510, the suture 514 can be tensioned as desired.

With the distal end of the inner shaft 510 positioned in the bone hole,the locking mechanism 518 is removed from the inserter 500. The outershaft 508 is now free to move relative to the inner shaft 510 inresponse to a strike on the strike cap 512.

With the distal end of the inner shaft 510 positioned in the bone hole,the anchor 102 is advanced distally into the bone hole by longitudinallytranslating the anchor 102 relative to the inner shaft 510 in a distaldirection by striking the strike cap 512 to distally advance the pushtube 508, similar to that discussed above regarding the inserter 100 ofFIG. 1 . The anchor 102 in the bone hole traps the suture 514 betweenthe exterior surface of the anchor 102 and the bone surface defining thebone hole.

After the anchor 102 has been inserted into the bone hole, the inserter500 is longitudinally translated in a proximal direction, e.g., pulledaxially along a longitudinal axis 504 of the inserter 500, to be removedfrom the patient's body with the anchor 102 and the suture 514 remainingin the bone. The proximal movement of the inserter 500 causes the snareto unfold itself due to one of the flexible member's ends being free andthe other of the flexible member's ends being fixedly attached to theinserter 500. The end of the flexible member 516 f attached to theinserter 500 moves proximally with the inserter 500 while the free endof the flexible member 516 f slides within the inserter 500 until thefree end of the flexible member 516 f exits the open distal end of theinner shaft 510 such that the loop 516 is open and no longer exists as aloop. Continued proximal movement of the inserter 500 causes the entireflexible member 516 f to exit the patient's body along with the inserter500. With the loop 516 being open and no longer being present, thesuture 514 is freed from the flexible member 516 f and can thus stayfixed in position in the bone hole. Tails of the suture 514 can betrimmed as desired. Although not showing the suture 514 positioned in abone hole, FIG. 22 illustrates the snare in its unfolded configurationand also shows the free end 516 e of the flexible member 516 f.

The snare in the illustrated embodiment of FIG. 17 is a passive snare inwhich the suture 514 extends through the loop 516 of the flexible member516 f and is freely slidable through the loop 516 until the anchor 502fixes the suture 514 in position relative to the bone. In otherembodiments, the snare can be an active snare in which the snaresecurely engages the suture in a loop of a flexible member such that thesuture extending through the loop is not freely slidable through theloop before or after the anchor fixes the suture in position relative tothe bone.

FIG. 23 illustrates another embodiment of an inserter tool 600 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 600 is generally configured and used similar to theinserter tool 500 of FIG. 17 , e.g., is configured to insert an anchorinto a bone of a patient to secure a soft tissue relative to the boneand includes a handle 606, an outer shaft 608 that extends distally fromthe handle 606, an inner shaft 610 that extends distally from the handle606, a strike cap 612 that extends proximally from the handle 606, and asnare defined by a loop of a flexible member 616 f. However, in thisillustrated embodiment, the snare is an active snare. The flexiblemember 616 f is a textile strand in this illustrated embodiment but canhave other configurations, e.g., a metal multi-filament wire, a braidedfabric, a metal single filament wire, etc.

The loop defined by the flexible member 616 f is generally configuredand used similar to the loop 516 defined by the flexible member 516 f,e.g., is located distal to the inner shaft 610 and is thus locateddistal to the anchor that has the inner shaft 610 positioned in an innerlumen thereof, has a horseshoe shape, and has one end 616 e fixedlyattached to the inserter 600 and has one end that is free so as to notbe fixedly attached to the inserter 600. However, in this illustratedembodiment, the end 616 e of the flexible member 616 f fixedly attachedto the inserter 600 is spring-loaded. The fixed end 616 e of theflexible member 616 f is operatively coupled to a spring 620 that isfixedly attached to the handle 606. The spring 620 is a coil spring inthis illustrated embodiment but can be another type of spring or biasmember. The spring 620 is configured to bias the flexible member 616 fin a proximal direction, e.g., in a direction toward the handle 606. Thespring 620 is thus configured to self-tension the loop on a suturepassed through the loop. The suture may therefore be held in a known,fixed position relative to the inner shaft 610, which may help ensurethe anchor engages an adequate length of each suture leg trapped betweenthe anchor and bone. The user can manually increase a size of the loopas desired to help position the suture in the loop by pulling on theflexible member 616 f, e.g., to move a length of the flexible member 616f out of the inner shaft 610 to increase a size of the loop before theuser releases the flexible member 616 f to allow the spring 620 totension the flexible member 616 f on the suture extending through theloop. The suture can be positioned in the loop defined by the flexiblemember 616 f by the user by hand, or the suture can be positioned in theloop defined by the flexible member 616 f using a loading aid, e.g., theloading aid 522 of FIG. 19 .

Similar to that discussed above, the free end of the loop defined by theflexible member 616 f can extend through the inner shaft 610 and out ofthe handle 606 to allow a user to tension the flexible member 616 f andthereby adjust a size of the loop. The handle 606 can include a sutureretention member, e.g., a slot formed in the handle 606 and configuredto releasably seat the suture therein in a cinch or pinch, a protrusionaround which the suture can be tied or wrapped, etc., to allow thetension on the flexible member 616 f to be maintained and thus for theloop size to be maintained.

As in this illustrated embodiment, a locking mechanism 618 can beconfigured to be releasably coupled to the inserter tool 600 to lock theouter shaft 608 in position relative to the inner shaft 610 when thelocking mechanism 618 is coupled to the inserter tool 600. The lockingmechanism 618 is generally configured and used similar to the lockingmechanism 118 of FIG. 1 .

FIG. 24 illustrates another embodiment of an inserter tool 700 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 700 is generally configured and used similar to theinserter tool 600 of FIG. 23 , e.g., is configured to insert an anchor702 into a bone of a patient to secure a soft tissue relative to thebone and includes a handle 706, an outer shaft 708 that extends distallyfrom the handle 706, an inner shaft 710 positioned inside the outershaft 708, a strike cap that extends proximally from the handle 706, anda snare that is active and that is defined by a loop 716 of a flexiblemember 716 f. A locking mechanism may be used. The loop 716 defined bythe flexible member 716 f is generally configured and used similar tothe loop defined by the flexible member 616 f, e.g., is located distalto the inner shaft 710 and is thus located distal to the anchor 702, hasa horseshoe shape, and has one end 716 e fixedly attached to theinserter 700 and has one end 716 r that is free so as to not be fixedlyattached to the inserter 700. However, in this illustrated embodiment,the fixed end 716 e of the flexible member 716 f is fixedly attached tothe inner shaft 710 and loops around a pulley 720 located proximal tothe inner shaft 710. The pulley 720 in this illustrated embodiment isfixedly attached to an inner wall of the outer shaft 708 but can be inanother location, such as in the handle 706. The fixed end 716 e of theflexible member 716 f is fixedly attached to the inner shaft 710 at aproximal surface thereof, e.g., by crimping, welding, tying, etc., butcan be attached to another portion of the inner shaft 710. The flexiblemember 716 f is a metal single filament wire in this illustratedembodiment but can have other configurations, e.g., a metalmulti-filament wire, a braided fabric, a textile strand, etc.

With the inserter 700 in an initial configuration, which is shown inFIGS. 24 and 25 , the anchor 702 is disposed in an inner lumen 708 i ofthe outer shaft 708. The inner shaft's distal end 708 d abuts theanchor's proximal end 702 p in the inserter's initial configuration. Theinner shaft 710 in this illustrated embodiment is thus configured to bepushed distally relative to the outer shaft 708, e.g., by striking thestrike cap, to cause the anchor 702 to advance distally out of the outershaft 708 to be implanted in bone. The distal advancement of the innershaft 710 relative to the outer shaft 708 causes the flexible member 716f to move around the pulley 720 and for the snare to unfold until thefree end 716 r of the flexible member 716 f exits an open distal end ofthe outer shaft 708 such that the loop 716 no longer exists, as shown inFIG. 26 . A first arrow 722 in FIG. 26 illustrates the distal movementof the anchor 702 and the inner shaft 710, and a second arrow 724 inFIG. 26 illustrates the simultaneous proximal movement of the flexiblemember 716 f into the outer shaft's inner lumen 708 i as the flexiblemember 716 f moves around the pulley 720.

The embodiments of the inserter tools 100, 500, 600, 700 discussed abovewith respect to FIGS. 1, 11, 12, 17, 23, and 24 are each configured toinsert an anchor and a suture into a bone of a patient that remain inthe bone after the inserter tool has been removed from the patient'sbody. In other embodiments, an inserter tool can be configured to insertan anchor, a suture, and a distal cap into a bone of a patient thatremain in the bone after the inserter tool has been removed from thepatient's body. In such embodiments, a flexible member need not be usedto define a loop for a suture to pass through because a suture caninstead pass through an enclosed passage defined by the distal cap andthe inserter tool's inner shaft.

FIG. 27 illustrates another embodiment of an inserter tool 800 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 800 is generally configured and used similar to theinserter tool 100 of FIG. 1 , e.g., is configured to insert an anchor802 into a bone of a patient to secure a soft tissue relative to thebone and includes a handle, an outer shaft 808 that extends distallyfrom the handle, an inner shaft 810 that extends distally from thehandle, and a strike cap that extends proximally from the handle. Alocking mechanism may be used. The anchor 802 is generally configuredand used similar to the anchor 102 of FIG. 1 .

However, in this illustrated embodiment, a notch 804 formed in a distalend of the inner shaft 810 does not fully define a suture retentionchannel. Instead, the notch 804 cooperates with a distal cap 812 todefine an enclosed passage 832 similar to the enclosed passage 532 ofthe loop 516 discussed above with respect to the inserter tool 500 ofFIG. 17 . FIG. 28 illustrates the outer shaft 808 and the inner shaft810 without a remainder of the inserter 800. FIG. 29 illustrates asuture 814 extending through the enclosed passage 832. The distal cap812 is configured to prevent the suture 814 from moving distally out ofthe enclosed passage 832 before a desired time of suture 814 decouplingfrom the inserter tool 800.

The anchor 802 has a distal groove 802 g formed therein configured toseat the suture 814 therein prior to advancement of the anchor 802 intobone, as shown in FIG. 29 . The distal groove 802 g is defined byopposed arcs formed in the anchor's distal end in this illustratedembodiment, but the distal groove 802 g can have another shape, e.g., ascalloped shape defined by a plurality of arcs formed in the anchor'sdistal end, opposed longitudinal slots, opposed rectangular notches,etc.

The distal cap 812 is located distal to the anchor 802 and is releasablycoupled to the inner shaft 810. The distal cap 812 is a solid member.The distal cap 812 can be absorbable or non-absorbable. The distal cap812 in this illustrated embodiment has a cylindrical body with a pointeddistally tapering tip, but the distal cap 812 can have another shape,e.g., cylindrical with no pointed distally tapering tip, cylindricalbody with a blunt distally tapering tip, square pyramidal, etc.

The inner shaft 810 is configured to decouple from the distal cap 812 inresponse to the inner shaft 810 being moved proximally to remove theinner shaft 810, and a remainder of the inserter tool 800, from apatient's body after the outer shaft 808 has been pushed distally, e.g.,via strike on the strike cap, to secure the anchor 802 and the suture814 in bone. The distal cap 812 can thus remain implanted in thepatient's body along with the anchor 802 and the suture 814. Thedecoupling of the inner shaft 810 from the distal cap 802 alsoeliminates the enclosed passage 832. FIG. 30 illustrates relativepositions of the distal cap 812, the anchor 802, and the suture 814after implantation in a bone hole 818 formed in bone 816. The distalgroove 802 g of the anchor 802 is also configured to seat the suture 814therein after advancement of the anchor 802 into the bone hole 818, asshown in FIG. 30 . However, depending one or more factors such as a sizeof the bone hole, a size of the suture, a size of the anchor 802, andthe tensioning applied to the suture 814, the suture 814 may not beseated in the groove 802 g after implantation but instead be locateddistal to the groove 802 g within the bone hole.

The suture 814 can be positioned in the enclosed passage 832 by a userby hand, or the suture 814 can be positioned in the enclosed passage 832using a loading aid. For example, the loading aid 522 of FIG. 19 can beused to load the suture 814 in the enclosed passage 832 similar to thatdiscussed above regarding the loading aid 522 being used to thread thesuture 514 through the loop 516. For another example, another embodimentof a loading aid 822 illustrated in FIG. 31 can be used to load thesuture 814 in the enclosed passage 832.

FIG. 31 illustrates the loading aid 822 positioned relative to theinserter tool 800 before the suture 814 is positioned in the enclosedpassage 832. In an exemplary embodiment, the loading aid 822 ispre-loaded on the inserter tool 800 during manufacturing, which may helpensure that the loading aid 822 is positioned correctly relative to theinner shaft 810 and the distal cap 812 and/or may provide a reminder toa user of the inserter 800 that the suture 814 should be coupled to theinserter 800 before the inserter 800 is advanced into a patient's body.Alternatively, the loading aid 822 can be loaded onto the inserter tool800 by a user, which may allow for the inserter 800 to be sold withoutthe loading aid 822 and thus at a lower cost than the inserter 800 soldwith the loading aid 822.

As shown in FIGS. 31 and 32 , the loading aid 822 includes a distalseating groove 824, a plunger 826, a sliding loader 828, a plurality ofguide members 830, and a cavity 834 formed therein.

The plurality of guide members 830 are configured as a seating guide forthe inner shaft 810 to position the inner shaft 810, and hence the notch804 thereof, at an optimal position relative to the distal cap 812 forsuture loading. The guide members 830 define a seating channel 836therebetween that is configured to seat the inner shaft 810 therein. Theguide members 830 are sized and shaped such that the seating channel 836has a size and shape that allows the inner shaft 810 to be releasablysnapped into and out of the seating channel 836. The guide members 830are alternately positioned on either side of the seating channel 836along a length of the seating channel 836. The loading aid 822 includesthree guide members 820 in this illustrated embodiment but can includeanother number of guide members. For example, the loading aid 822 caninclude two guide members 830 that each extend along an entire length ofthe seating channel 836 defined therebetween. For another example, theloading aid can include four or more guide members 830 alternatelypositioned on either side of the seating channel 836 along a length ofthe seating channel 836. The guide members 830 each include elongaterectangular blocks in this illustrated embodiment but can have anothershape, e.g., half-domes, square blocks, etc.

The distal seating groove 824 is defined by opposed distal wings 838 ofthe loading aid 822. The distal wings 826 each extend radially outwardso as to define a V-shape. The distal seating groove 824 is thusV-shaped.

The cavity 834 is located at an apex of the V-shaped distal seatinggroove 824 and is located distal to the seating channel 836. The notch804 of the inner shaft 810 is thus positioned proximal to the cavity 834with the inner shaft 810 and the distal cap 812 coupled to the loadingaid 822, as shown in FIG. 32 . The enclosed passage 832 does not yetexist in FIGS. 31 and 32 .

As shown in FIG. 31 , the suture 814 is positioned within the distalseating groove 824 of the loading aid 822. The suture 814 is then, asshown in FIG. 6 , positioned on an inner surface 838 s of one of thedistal wings 838 and slid proximally along the distal wing's innersurface 838 s to guide the suture 814 to the apex of the distal seatinggroove 824, e.g., to the point of the V-shape. The suture 814 can beslid along either of the distal wing's inner surface 838 s. The suture114 continues to be slid proximally to enter the notch 804 of the innershaft 810. A proximal surface of the notch 804 acts as a stop surfacefor the suture 814 in the notch 804, although in some embodiments thesuture 814 may be positioned in the notch 804 but not abut the stopsurface.

With the suture 814 positioned in the notch 804, the sliding loader 828is actuated to cause the distal cap 812 to move into the cavity 834. Thesliding loader 828 is configured to be actuated by sliding the loader828 radially inward, e.g., by a user pressing on a head of the loader828, which causes the distal cap 812 previously seated in the loadingaid 822 to move radially inward and into the cavity 834. FIG. 32illustrates the loading aid 822 after the actuation of the slidingloader 828. The distal cap 812 not being seated in the cavity 834 beforethe suture 814 is positioned in the notch 804 allows the suture 814 toslide into the notch 804 from the distal seating cavity 824.

With the distal cap 812 seated in the cavity 834, the plunger 826 isactuated to cause the distal cap 812 to be pushed proximally toward theinner shaft 810 and thereby form the enclosed passage 832 with thesuture 814 extending through the enclosed passage 832. The plunger 826is configured to be actuated by sliding the plunger 826 proximally,e.g., by a user pressing on a head of the plunger 826, which causes thedistal cap 812 to move out of the cavity 834 and be seated on a distalend of the inner shaft 810. FIG. 33 illustrates the loading aid 822after the actuation of the plunger 826. The inserter tool 800 can thenbe removed from the loading aid 822, with the suture 814 extendingthrough the enclosed passage 834, by releasing the inner shaft 810 fromthe guide members 830, e.g., by snapping the inner shaft 810 out of theseating channel 836.

As mentioned above with respect to the inserter tool 500 of FIG. 17 ,the inserter tool 500 can include a suture retention member configuredto releasably retain a suture to hold the suture in a desired positionat a desired tension. Any of the inserter tools described herein caninclude a suture retention member. A suture is traditionally retainedusing a hemostat. The inserter tool including a suture retention membermay eliminate the need to use any hemostats for the suture.

FIG. 34 illustrates another embodiment of an inserter tool 900 forknotless anchor insertion in a soft tissue repair surgical procedure. Ahandle 906 of the inserter tool 900 can be similarly used as the handlefor any of the inserter tool handles described herein.

As shown in FIGS. 34-37 , the handle 906 includes a suture retentionmember 904 configured to releasably retain a suture to hold the suturein a desired position at a desired tension. The suture retention member904 is located at a distal end of the handle 906, which may help avoidinterference with a user's holding of the handle 906. The sutureretention member 904 can, however, be located elsewhere on the handle906. The suture retention member 904 in this illustrated embodimentincludes a groove 904 g formed in the handle 906 configured to seat asuture therein. The groove 904 g can have any of a variety of shapes,e.g., U-shaped, V-shaped, a half-dome shape, W-shaped,rectangular-shaped, etc. The suture retention member 904 also includes arocker switch 904 r configured to be selectively moved in and out ofalignment with the groove 904 g. In some embodiments, the rocker switch904 r can be spring-biased to be in alignment with the groove 904 g,which may help retain the suture in a fixed position in the groove 904g.

One or more surfaces of the handle 906 that define the groove 904 g caninclude a gripping feature 904 f thereon that is configured tofacilitate grip of the suture within the groove 904 g. The grippingsurface 904 f is configured to provide friction with the suture to helpretain the suture in a fixed position in the groove 904 g when therocker switch 904 r is in alignment with the groove 904 g. In anexemplary embodiment, at least a surface 906 s of the handle 906 thatfaces the rocker switch 904 r includes the gripping feature 904 f, as inthis illustrated embodiment, since the rocker switch 904 r urges thesuture against that surface 906 s when in alignment with the groove 904g. The gripping feature 904 f includes a ribbed textured surface in thisillustrated embodiment but can have other configurations, such asanother type of textured surface, surface projections, etc.

FIGS. 34-36 show the rocker switch 904 r out of alignment with thegroove 904 g. FIG. 37 shows the rocker switch 904 r in alignment withthe groove 904 g and with a suture 914 seated in the groove 904 g andretained by the suture retention member 904. FIG. 37 also shows oneembodiment of a method of using the inserter tool 900 that includes thesuture retention member 904 in a surgical procedure. The surgicalprocedure is at a shoulder joint in this illustrated embodiment, but asmentioned above, the inserter tool 900 and other embodiments of insertertools described herein can be used in a variety of other surgicalprocedures. As shown in FIG. 37 , a cannula 912 can be positioned inskin 944 of a patient. The suture 914 can extend through an inner lumen912 i of the cannula 912 into the patient's body, e.g., to a soft tissuetherein to be secured in position relative to bone. With the suture 914extending into the patient's body, a drill or other bone removal toolcan be advanced through the inner lumen 912 i of the cannula 912 intothe patient's body to form a bone hole. The drill or other bone removaltool can then be removed from the cannula 912. The inserter tool 900 canthen be “zipped” down the suture 914 and through the inner lumen 912 iof the cannula 912 to position a distal end of the inserter tool 900within the bone hole. The suture 914 can be released from the sutureretention feature 904 at any time and repositioned therein any number oftimes as desired.

The strike surface of each of the strike caps 112, 512, 612 illustratedin FIGS. 1, 17, and 23 is exposed for striking by a mallet, hammer, orother tool. In other embodiments, an inserter tool can include a strikecap and a protective member configured to cover or hide at least thestrike surface of the strike cap. The protective member may help preventpremature striking of the strike cap and/or any unintentional distalmovement of the strike cap and thus any unintentional distal advancementof an anchor coupled to the inserter tool. In some embodiments theprotective member can completely cover or hide the strike cap.

FIGS. 38-41 illustrate another embodiment of an inserter tool 1000 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 1000 in this illustrated embodiment includes aprotective member 1004 configured to cover or hide a strike cap 1012 ofthe inserter tool 1000. The protective member 1004 can be used with anyof the inserter tools described herein.

The protective member 1004 is configured to move between a closedposition, which is shown in FIGS. 38 and 39 , and an open position,which is shown in FIGS. 40 and 41 . FIG. 41 also illustrates oneembodiment of a mallet 1016 configured to strike the strike cap 1012. Inthe closed position, the protective member 1004 covers or hides at leasta strike surface 1012 s of the strike cap 1012. The entire strike cap1012 s is covered or hidden by the strike cap 1012 with the strike cap1012 in the closed position in this illustrated embodiment. In the openposition, at least the strike surface 1012 s of the strike cap 1012 isexposed. The entire strike cap 1012 s is exposed with the strike cap1012 in the open position in this illustrated embodiment.

The protective member 1004 is configured to move from the closedposition to the open position, and vice versa, in flip-top fashion. Theprotective member 1004 is attached to a handle 1006 of the inserter tool1000 with a living hinge 1014. The protective member 1004 can instead beattached to the handle 1006 of the inserter tool 1000 with another typehinge. The hinge 1014 is configured to keep the protective member 1004to the handle 1006 regardless of whether the protective member 1004 isin the closed position or the open position. The protective member 1004can be flipped open and closed with one hand, which may ease usabilityby allowing a user to open or close the protective member 1004 withoutchanging hand grip of the handle 1006.

FIGS. 42-48 illustrate another embodiment of an inserter tool 1100 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 1100 is generally configured and used similar to theinserter tool 100 of FIG. 1 , e.g., is configured to insert an anchor1102 into a bone of a patient to secure a soft tissue relative to thebone and includes a handle 1106, an outer shaft 1108 that extendsdistally from the handle 1106, an inner shaft 1110 that extends distallyfrom the handle 1106, and a strike cap 1112 that extends proximally fromthe handle 1106. The anchor 1102 is generally configured and usedsimilar to the anchor 102 of FIG. 1 .

However, unlike the inserter tools discussed above, the outer and innershafts 1108, 1110 in this illustrated embodiment are not linear.Instead, the outer and inner shafts 1008, 1110 curve in a distal portionthereof, as shown in FIGS. 42, 44, 45, and 47 . Although the outer andinner shafts 1108, 1110 are curved in this illustrated embodiment, theouter and inner shafts 1108, 1110 can instead be linear. Similarly, theabove-discussed inserter tools can have curved inner and outer shaftsinstead of linear inner and outer shafts. The outer and inner shafts1008, 1110 being curved in distal portion thereof may facilitateapproach of the inserter tool's distal end to a target site forimplantation of the anchor 1102 since the tight constraints of patientanatomy at joints can make it difficult to approach a target site. Thecurvature of the outer and inner shafts 1008, 1110 is fixed in thisillustrated embodiment.

Additionally, in this illustrated embodiment, an opening 1104 is formedin a distal end of the inner shaft 1110, as shown in FIGS. 44, 45, 47,and 48 , is configured to seat a suture therein. The opening 1104defines an enclosed passage in which the suture is configured to extend,similar to the enclosed passages discussed above. The opening 1104 hasan ovular cross-sectional shape in this illustrated embodiment but canhave another cross-sectional shape, e.g., circular, rectangular, etc.The distal end of the inner shaft 1110 in this illustrated embodiment isclosed distal end. The closed distal end is rounded in this illustratedembodiment.

FIG. 44 illustrates the inner shaft 1110 in a loading position in whichthe opening 1104 is located distal of the anchor 1102 and distal to anopen distal end of the outer shaft 1108. The opening 1104 is thereforeaccessible for suture loading therethrough. In some embodiments, thesuture is positioned in the opening 1104 during manufacturing. A user ofthe inserter tool 1100 thus receives the inserter tool 1100 with thesuture pre-loaded in the inserter tool 1100. In other embodiments, thesuture is positioned in the opening 1104 by a user of the inserter tool1100, which may provide a user of the inserter 1100 flexibility indeciding on a size and type of suture to use that is appropriate for aparticular patient and a particular surgical procedure. The suture canbe positioned in the opening 1104 by the user by hand, similar to thethreading of a needle. Alternatively to hand positioning, the suture canbe positioned in the opening 1104 using a loading aid, e.g., the loadingaid 522 of FIG. 19 .

With the suture extending through the opening 1104, the distal end ofthe inner shaft 1110 is advanced distally into a bone hole. The inserter1100 includes a collar 1118 that is operatively coupled to the innershaft 1110, as shown in FIG. 43 . Sliding the collar 1118 relative tothe handle 1106 causes the inner shaft 1110 to move distally relative tothe anchor 1102 and the outer shaft 1108 so as to extend a distancedistally beyond the outer shaft 1108 and the anchor 1102, as shown inFIG. 45 . The opening 1104 is this located a distance distally beyondthe outer shaft 1108 and the anchor 1102 and is positioned in the bonehole. The distance that the inner shaft 1110 is advanced distally beyondthe outer shaft 1108 and the anchor 1102 will vary based on a depth ofthe bone hole into which the inner shaft 1110 is being advanced.

The collar 1118 includes opposed finger holds 1118 f that extendradially through slots 1114 formed in the handle 1106. The finger holds1118 f are configured to provide a surface easily held by hand duringmovement of the collar 1118. By including finger holds 1118 f on opposedsides of the collar 1118, the collar 1118 may be conveniently held by aleft hand or a right hand and be in an easily held position regardlessof the loading aid's rotational position relative to the user. One ofboth of the finger holds 1118 f may be held at a time. The finger holds1118 f move distally in the slots 1114 as the collar 1118 moves distallyrelative to the handle 1106.

The inserter tool 1100 includes a spring 1116 disposed in the handle1106 and operatively coupled to the collar 1118. The spring 1116 is acoil spring in this illustrated embodiment but can be another type ofspring or bias member. The spring 1116 biases the collar 1118proximally. The inner shaft 1110 is thus biased proximally. The distaladvancement of the collar 1118 relative to the handle 1106 causes thespring 1116 to compress. The collar 1118 can be locked in positionrelative to the collar 1118 in a distally advanced position so as tolock the inner shaft 1110 in a distally advanced position relative tothe outer shaft 1108 and the anchor 1102. The inner shaft 1110 iscoupled to the collar 1118, so when the collar 1118 is locked in thedistal position the collar 1118 also locks the inner shaft 1110distally.

With the inner shaft 1110 and the opening 1104 with the suture extendingtherethrough positioned in the bone hole, the anchor 1102 is advanceddistally by striking the strike cap 1112 with a mallet, hammer, or othertool. Striking the strike cap 1112 does not cause the outer shaft 1108to move distally to push the anchor 1102 distally in this illustratedembodiment. Instead, a distal extension of the strike cap 1112 extendsdistally through the outer shaft 1108, as shown in FIG. 43 , such that adistal surface of the strike cap 1112 abuts a proximal surface of theanchor 1102. The striking of the strike cap 1112 thus causes the strikecap 1112 to move distally and push the anchor 1102 distally relative tothe outer and inner shafts 1108, 1110. FIGS. 45, 47, and 48 show theanchor 1102 partially distally advanced out of the outer shaft 1108.

As discussed above, the advancement of the anchor 1102 into the bonehole causes bone-engaging surface features 1102 f of the anchor 1102 toengage a wall of the bone hole to secure the anchor 1102 therein andsecure the suture relative to the bone. The bone-engaging surfacefeatures 1102 f in this illustrated embodiment include a plurality ofribs each extending circumferentially around the anchor 1102 atdifferent axial positions along the anchor's longitudinal length. Eachof the ribs has a scalloped proximal edge, which may further facilitatethe anchor's engagement with bone. As shown in FIG. 48 , the ribs arenarrower in a proximal portion of the anchor 1102 than in a distalportion of the anchor 1102. The narrower ribs may facilitate anchorengagement with cortical bone, and the wider ribs may facilitate anchorengagement with cancellous bone that underlies the cortical bone.

With the anchor 1102 positioned in the bone hole, and trapping thesuture therein as discussed above, the inserter tool 1100 can be removedfrom the patient's body. The collar 1118 can be moved proximallyrelative to the handle 1106 to cause the inner shaft 1110 to moveproximally so as to retract relative to the anchor 1102, the outer shaft1108, and the handle 1106. The inner shaft 1110 can thereby be removedfrom the cannulated anchor's inner lumen 1102 i. The inserter tool 1110can then be removed from the patient's body by moving the outer andinner shafts 1108, 1110 proximally by pulling the inserter 1100proximally by the handle 1106. Tails of the suture can be trimmed asdesired.

FIGS. 49-54 illustrate another embodiment of an inserter tool 1200 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 1200 is generally configured and used similar to theinserter tool 100 of FIG. 1 , e.g., is configured to insert an anchor1202 into a bone of a patient to secure a soft tissue relative to thebone and includes a handle 1206, an outer shaft 1208 that extendsdistally from the handle 1206, an inner shaft 1210 that extends distallyfrom the handle 1206 and includes a notch formed therein that defines asuture retention channel 1204, and a strike cap 1212 that extendsproximally from the handle 1206.

The anchor 1202 is generally configured and used similar to the anchor102 of FIG. 1 . FIG. 51A illustrates the anchor as a standalone element.A plurality of bone-engaging surface features 1202 f are formed on anexterior surface of the anchor 1202. The bone-engaging surface features1202 f in this illustrated embodiment include a plurality of ribs eachextending circumferentially around the anchor 1202 at different axialpositions along the anchor's longitudinal length. The anchor 1202 inthis illustrated embodiment includes a plurality of gussets 1202 g thatare configured to reinforce the anchor 1202. The gussets 1202 g eachextend longitudinally along the anchor 1202. A first set of the gussets1202 g 1 are aligned with one another along the anchor's length, asecond set of the gussets 1202 g 2 are aligned with one another alongthe anchor's length, a third set of the gussets 1202 g are aligned withone another along the anchor's length, and a fourth set of the gussets1202 g are aligned with one another along the anchor's length. The thirdand fourth sets of gussets 1202 g are obscured in FIG. 51A. The first,second, third, and fourth sets of gussets 1202 g are arrangedequidistantly around the circumference of the anchor 1202, which mayhelp reinforce the anchor 1202 around the entire circumference thereof.In other embodiments, and anchor can include a different number of setsof gussets and/or the sets of gussets can be non-equidistantly arrangedaround the anchor's circumference.

The notch and the suture retention channel 1204 in this illustratedembodiment are generally configured and used similar to the notch andthe suture retention channel 116 of FIG. 1 , e.g., the notch is formedin a distal end of the inner shaft 1210 and is defined by opposed distalarms 1220 of the inner shaft 1210, the suture retention channel 1204 hasan open distal end and a closed proximal end, and the suture retentionchannel 1204 extends longitudinally. The suture retention channel 1204has a substantially constant diameter in this illustrated embodiment butcan have different diameters in different portions, e.g., a proximalportion of the suture retention channel 1204 having a greater diameterthan a distal portion of the suture retention channel, a distal portionof the suture retention channel 1204 having a greater diameter than aproximal portion of the suture retention channel, or other differentdiameters. A person skilled in the art will appreciate that values, suchas diameter values, may not be precisely the same but neverthelessconsidered to be substantially the same for any of one or more reasons,such as manufacturing tolerances or sensitivity of measurementequipment.

The handle 1206 in this illustrated embodiment includes facets 1206 f onopposed sides, e.g., left and right sides, thereof. The facets 1206 fare configured to help a user with grip and fine motor movements.

In this illustrated embodiment, the inserter tool 1200 includes apliable member 1216. As mentioned above, a “pliable member” is alsoreferred to herein as a “flexible member.” The pliable member 1216 isconfigured to fold or bend without breaking, cracking, or otherwiselosing structural integrity. The pliable member 1216 is a metal singlefilament wire in this illustrated embodiment but can have otherconfigurations, e.g., a metal multi-filament wire, a braided fabric, atextile strand, a monofilament fiber, etc.

The pliable member 1216 is located distal to the anchor 1202 that hasthe inner shaft 1210 positioned in an inner lumen thereof. The pliablemember 1216 has a first end 1216 a fixedly attached to the inner shaft1210 and has a second end 1216 b that is free so as to not be fixedlyattached to the inner shaft 1210.

The first end 1216 a of the pliable member 1216 can be fixedly attachedto the inner shaft 1210 in any of one or more ways, such as by beingcrimped to the inner shaft 1210, adhered to the inner shaft 1210 usingadhesive, welded to the inner shaft 1210, or attached using anotherattachment mechanism. In this illustrated embodiment, the inner shaft1210 includes a cavity 1218 formed therein that is configured to fixedlyseat the first end 1216 a of the pliable member 1216 therein. The firstend 1216 a of the pliable member 1216 is fixedly attached to the innershaft 1210 in the cavity 1218. The cavity 1218 is formed in a sidewallof the inner shaft 1210 and extends substantially perpendicular to alongitudinal axis of the inner shaft 1210, and thus substantiallyperpendicular to a longitudinal axis of the outer shaft 1208 that iscoaxial with the longitudinal axis of the inner shaft 1210. A personskilled in the art will appreciate that axes may not be preciselyperpendicular but nevertheless considered to be substantiallyperpendicular for any of one or more reasons, such as manufacturingtolerances or sensitivity of measurement equipment. The cavity 1218extending substantially perpendicular to the longitudinal axis of theinner shaft 1210 may help prevent the first end 1216 a of the pliablemember 1216 from being detached from the inner shaft 1210 duringmovement of the pliable member 1216, as discussed further below. Thecavity 1218 is formed in the inner shaft 1210 proximal to the arms 1220and distal to the anchor 1202, as shown in FIGS. 52 and 53 .

The inner shaft 1210 includes a groove 1222 configured to releasablyseat the second end 1216 b of the pliable member 1216 therein. Thegroove 1222 is formed in a first one of the inner shaft's distal arms1220 and extends into the distal arm 1220 and through a distal tip ofthe distal arm 1220. The groove 1222 is formed on an opposite side,e.g., right side opposed to the left side, of the inner shaft 1210 thanthe cavity 1218. Release of the second end 1216 b of the pliable member1216 from the groove 1222, e.g., movement of the second end 1216 bdistally out of the groove 1222, will thus urge the pliable member 1216toward the side of the inner shaft 1210 in which the cavity 1218 isformed.

The inner shaft 1210 also includes a hole 1224 formed therein configuredto seat the pliable member 1216 therein. The hole 1224 is locatedbetween the cavity 1218 and the groove 1222 such that an intermediateportion of the pliable member 1216 that is located between the first andsecond ends 1216 a, 1216 b of the pliable member 1216 extends throughthe hole 1224. The hole 1224 is formed in the one of the inner shaft'sdistal arms 1220 that does not have the groove 1222 formed therein andis formed on a same side of the inner shaft 1210 as the cavity 1218. Thehole 1224 is configured to help constrain bending movement of thepliable member 1216 to a distal portion of the pliable member 1216 thatextends from the hole 1224 to the groove 1222, which may help preventthe pliable member 1216 from tangling with or otherwise interfering withany matter during surgical use.

The pliable member 1216 defines an enclosed passage 1232 in cooperationwith the distal end of the inner shaft 1210. The inner shaft 1210defines three sides of the enclosed passage 1232, with a distal surfaceof the inner shaft 1210 defining a proximal side of the enclosed passage1232 and the distal arms 1220 defining opposed sides (e.g., left andright sides) of the enclosed passage 1232. The pliable member 1216defines a fourth and final side of the enclosed passage 1232. Inparticular, the distal portion of the pliable member 1215 that extendsbetween the hole 1224 and the groove 1222 defines the fourth and finalside of the enclosed passage 1232, A suture is configured to extendthrough the suture retention channel 1216 and the enclosed passage 1232during use of the inserter tool 1200, similar to that discussed aboveregarding the suture retention channel 116 and as discussed furtherbelow. The pliable member 1216 is configured to move to open theenclosed passage 1232 and thereby allow release of the suture from thesuture retention channel 1216, as also discussed further below. Ingeneral, the pliable member 1216 is configured to move out of the groove1222 and bend to open the enclosed passage 1232 by no longer providingthe fourth side of the enclosed passage 1232.

In an exemplary embodiment, the pliable member 1216 is made from asuperelastic material, such as Nitinol or other material. The pliablemember 1216 can have a default bent shape that corresponds to a shape ofthe pliable member 1216 with the pliable member 1216 seated in thegroove 1222 and cooperating with the inner shaft 1210 to form theenclosed passage 1232, which may help ensure that the second end 1216 bof the pliable member 1216 remains seated in the groove 1222 untildesired.

The handle 1206 in this illustrated embodiment includes a sutureretention member 1234 configured to releasably retain a suture to holdthe suture in a desired position at a desired tension. The sutureretention member 1234 is located at a distal end of the handle 1206 butas mentioned above can be located elsewhere. The suture retention member1234 in this illustrated embodiment includes a pair of grooves onopposed sides, e.g., left and right sides, of the handle 1206. Providingthe suture retention member 1234 on opposed sides of the handle 1206 mayhelp accommodate use of the inserter tool 1200 by left-handed andright-handed users and/or may facilitate engaging the suture with one ofthe suture retention members 1234 regardless of an orientation at whichthe inserter tool 1200 is being held and an angle of the suture'sapproach to the handle 1206.

A first one of the suture retention grooves is defined between thehandle 1206 and a first elastomeric cleat 1236 a fixedly attached to thehandle 1206. A second one of the suture retention grooves is definedbetween the handle 1206 and a second elastomeric cleat 1236 b fixedlyattached to the handle 1206. The first and second elastomeric cleats1236 a, 1236 b are each made from an elastomeric material, such asrubber or other polymer. The handle 1206 is made from a rigid,non-elastomeric material, such as a plastic such as polycarbonate orother plastic; metal (e.g., stainless steel, titanium, etc.);polytetrafluoroethylene (PTFE); or other biocompatible material. Thegrooves are thus each located at a junction between an elastomericmaterial and a rigid material. The elastomeric material of the first andsecond elastomeric cleats 1236 a, 1236 b allows a width of the grooveassociated therewith to dynamically increase to adjust to a size andshape of the suture being seated therein to securely hold the suture inthe groove, gripped between the elastomeric material and the rigidmaterial. The suture retention member 1234 is thus self-adjusting.Different sutures have different sizes and shapes, and the first andsecond elastomeric cleats 1236 a, 1236 b are each configured todynamically adjust to the particular size and shape of a suture beingseated therein. The suture being securely held in the groove may helpthe suture's tension be maintained, e.g., without being lessened, whilethe suture is retained by the suture retention member 1234. When thesuture is released from the groove, the elastomeric cleat 1236 a, 1236 bis no longer gripping the suture and is thus allowed to return to itsoriginal, smaller width as the elastomeric material elastically returnsto its original configuration.

The suture retention member 1234 is located at a hammerhead shapedportion of the inserter tool 1200 defined by the handle 1206 and theelastomeric cleats 1236 a, 1236 b. A proximal surface of the hammerheadshaped portion defined by a proximal surface of the handle 1206 and aproximal of each of the elastomeric cleats 1236 a, 1236 b, extendsradially outward and tapers distally. The tapering is configured to urgea suture along the proximal surface of the handle 1206 toward one of theelastomeric cleats 1236 a, 1236 b for seating the groove associatedtherewith. Each of the elastomeric cleats 1236 a, 1236 b has a bevelededge facing its associated groove, which may also help urge the sutureinto the groove.

As in this illustrated embodiment, a locking mechanism 1238 can beconfigured to lock the outer shaft 1208 in position relative to theinner shaft 1210 when the locking mechanism 1238 is in a lockedposition. FIGS. 55, 57, and 58 show the locking mechanism 1238 in thelocked position. FIGS. 49 and 54 show the locking mechanism 1238 in anunlocked position, in which the outer shaft 1208 is not locked inposition relative to the inner shaft 1210. The locking mechanism 1238 isconfigured to move from the locked position to the unlocked position bysliding relative to the outer shaft 1208, the inner shaft 1210, thestrike cap 1212, and the handle 1206. The sliding movement of thelocking mechanism 1238 is lateral movement substantially perpendicularto the longitudinal axes of the outer and inner shafts 1208, 1210. Theinitial position of the locking mechanism 1238 is the locked position,to help prevent premature distal translation of the outer shaft 1208relative to the inner shaft 1210.

The locking mechanism 1238 includes a depression 1238 d on a sidethereof. The depression 1238 d is configured to communicate where afinger should be placed on the locking mechanism 1238. The depression'ssurface is configured as a push surface on which a finger can be placedto push the locking mechanism 1238 from the locked position to theunlocked position. A curvature of the depression 1238 matches acurvature of the handle 1206 adjacent to the locking mechanism 1238 inthe unlocked position. The matching curvature of the depression 1238 andthe handle 1206 is configured to indicate to a user that the lockingmechanism 1238 has fully moved to the unlocked position.

The locking mechanism 1238 includes a keyhole 1240 formed therein inwhich the outer shaft 1208 and the strike cap 1212 are each configuredto move. The keyhole 1240 includes a reduced diameter portion 1240 a andan enlarged diameter portion 1240 b. With the locking mechanism 1238 inthe locked position, the outer shaft 1208 extends through the reduceddiameter portion 1240 a and the strike cap 1212 is located proximal tothe keyhole 1240. The diameter of the reduced diameter portion 1240 a isless than a diameter of the strike cap 1212 at least at the distal endof the end cap 1212. The strike cap 1212 thus cannot move distally intothe keyhole 1240, thereby preventing the outer shaft 1208 from movingdistally by the strike cap 1212 being struck on its proximal surface1212 s. The proximal surface 1212 s in this illustrated embodiment isconvex curved, which may provide more feedback (compared to a flatsurface) to a user striking the strike cap 1212. With the lockingmechanism 1238 in the unlocked position, the outer shaft 1208 extendsthrough the enlarged diameter portion 1240 b and the strike cap 1212 islocated proximal to the keyhole 1240. The diameter of the enlargeddiameter portion 1240 b is greater than the diameter of the strike cap1212 at least at the distal end of the strike cap 1212. The strike cap1212 thus can move distally into the keyhole 1240, thereby allowing theouter shaft 1208 to move distally by the strike cap 1212 being struck onits proximal surface 1212 s. The diameter of the enlarged diameterportion 1240 b is less than a diameter of a head of the strike cap 1212that includes the proximal surface 1212 s, thereby preventing the strikecap 1212 from fully passing into the keyhole 1240 because a distalsurface of the strike cap 1212 will abut the locking mechanism 1328around the keyhole 1240. FIG. 56 shows the locking mechanism 1238 in theunlocked position after the strike cap 1212 has been struck with thedistal surface of the strike cap 1212 abutting the locking mechanism1238 around the keyhole 1240.

The locking mechanism 1238 in this illustrated embodiment is notreleasable from the inserter tool 1200.

The suture is positioned in the enclosed passage 1232 by a user of theinserter tool 1200, which may provide a user of the inserter tool 1200flexibility in deciding on a size and type of suture to use that isappropriate for a particular patient and a particular surgicalprocedure. The suture can be positioned in the enclosed passage 1232 bythe user by hand, similar to the threading of a needle. Alternatively tohand positioning, the suture can be positioned in the enclosed passage1232 using a loading aid such as the loading aid 1242 illustrated inFIGS. 57 and 58 .

The loading aid 1242 in this illustrated embodiment includes a suturethreader. A suture threader can have a variety of configurations, aswill be appreciated by a person skilled in the art. In this illustratedembodiment, the loading aid 1242 is generally configured and usedsimilar to the loading aid 522, e.g., includes a base 1244 and a wireloop 1246 that is attached to the base 1244 and that defines an enclosedpassage 1248. The wire loop 1246 is formed by a metal single filamentwire in this illustrated embodiment but can have other configurations,similar to the loop 516 discussed above. A suture is configured to beseated in the passage 1248 defined by the loop 1246. The suture can becoupled to the loading aid 1242 by a user, which may provide a user ofthe inserter tool 1200 flexibility in deciding on a size and type ofsuture to use that is appropriate for a particular patient and aparticular surgical procedure and/or may allow for the inserter tool1200 to be sold without the loading aid 1242 and thus at a lower costthan the inserter tool 1200 sold with the loading aid 1242.

The loading aid 1242 in this illustrated embodiment is configured to bereleasably attached to the inserter tool 1200. FIGS. 57 and 58 show theloading aid 1242 releasably attached to the inserter tool 1200. The base1244 of the loading aid 1242 includes a plurality of clips 1252configured to releasably clip to the outer shaft 1208 to releasablyattach the loading aid 1242 to the inserter tool 1200. The loading aid1242 includes three clips 1252 in this illustrated embodiment, with twoof the clips 1252 clipping to one side of the outer shaft 1208 and athird one of the clips 1252 located between the other two clips 1252clipped to the other side of the outer shaft 1208, but the loading aid1242 can include another number of clips 1252.

With the suture 1250 extending through the loop 1246 of the loading aid1242, the loading aid 1242 can be pulled by the base 1244 in thedirection of arrow 1254 on the base 1244, e.g., printed thereon, etchedtherein, adhered thereon as a sticker, etc., to release the clips 1252from the outer shaft 1208 and to pull the suture 1250 through theenclosed passage 1232 defined by the inner shaft 1210 and the pliablemember 1216 so as to thread the suture 1250 through the enclosed passage1232. A location of the arrow 1254 on the base 1244 indicates to a userwhere to hold the loading aid 1242 during removal of the loading aid1242 from the inserter tool to which the loading aid 1242 is coupled.The suture 1250 can then be released from the loading aid 1242 by beingremoved from the loading aid's passage 1248 defined by the loop 1246.FIG. 59 illustrates a suture 1250 released from the loading aid 1242 andextending through the enclosed passage 1232. The suture 1250 extendingthrough the enclosed passage 1232 can thus be releasably coupled to theinserter tool 1200 and have a U-shape with the inserter tool 1200 in itsinitial configuration, similar to that discussed above regarding thesuture 114 and the inserter 100 of FIG. 2 . The suture 1250 is generallyconfigured and used similar to the suture 114 of FIG. 2 and, similar tothat discussed above regarding the suture 114, includes two strands inthis illustrated embodiment but can include another number of strands.

With the suture 1250 coupled to the inserter tool 1200, and with theloading aid 1242 removed if the loading aid 1242 was used to facilitatesuture coupling to the inserter tool 1200, the inserter tool 1200 can beused to insert the suture 1250 and the anchor 1202 into a bone hole. Inan exemplary embodiment of using the inserter tool 1200 to insert thesuture 1250 and the anchor 1202 into a bone hole, a drill or other boneremoval tool is inserted into a patient's body to form the bone hole,similar to that discussed above regarding the inserter 100 of FIG. 1 .

The inserter tool 1200 is advanced distally into the body of the patientand positioned with the distal end of the inner shaft 1210 within thebone hole and thus with the enclosed passage 1232 within the bone hole.The suture 1250 that extends through the enclosed passage 1232 is thuspositioned in the bone hole before the anchor 1202 is secured in thebone hole. A bottom surface of the bone hole can act as a stop surfacethat stops distal movement of the inserter tool 1200 relative to thebone, similar to that discussed above regarding the inserter 100 of FIG.1 .

With the distal end of the inner shaft 1210 positioned in the bone hole,and prior to distal advancement of the anchor 1250 relative to the innershaft 1210, the suture 1250 can be tensioned as desired and can beretained by the suture retention member 1234.

With the distal end of the inner shaft 1210 positioned in the bone hole,the locking mechanism 1238 is moved from the locked position to theunlocked position, as discussed above. The outer shaft 1208 is now freeto move relative to the inner shaft 1210 in response to a strike on thestrike cap 1212. With the distal end of the inner shaft 1210 positionedin the bone hole, the anchor 1202 is advanced distally into the bonehole by longitudinally translating the anchor 1202 relative to the innershaft 1210 in a distal direction by striking the strike cap 1212 todistally advance the outer shaft 1208, similar to that discussed aboveregarding the inserter 100 of FIG. 1 . The anchor 1202 in the bone holetraps the suture 1250 between the exterior surface of the anchor 1202and the bone surface defining the bone hole. FIG. 60 shows a distalforce (represented by arrows 1254) being applied to the anchor 1202 fromthe distal movement of the outer shaft 1208 caused by the strike on thestrike cap 1212. FIG. 61 shows continued application of the distal forcebeing applied to the anchor 1202 with the anchor 1202 having moveddistally from its position in FIG. 60 . The outer shaft 1208 abuts aproximal end 1202 p of the anchor 1202 in FIG. 61 (and in FIG. 60 ) butis not shown for clarity of illustration. FIG. 62 shows the anchor 1202fully advanced distally as caused by the distal, axial translation ofthe outer shaft 1208, e.g., with the strike cap's distal surfaceabutting the locking mechanism 1238 as discussed above.

After the anchor 1202 has been inserted into the bone hole, the insertertool 1200 is longitudinally translated in a proximal direction, e.g.,pulled axially along a longitudinal axis 1204 of the inserter tool 1200as shown by an arrow 1256 in FIGS. 63-65 , to be removed from thepatient's body with the anchor 1202 and the suture 1250 remaining in thebone. The proximal movement of the inserter tool 1200 causes the pliablemember 1216 to bend due to the second end 1216 b of the pliable member1216 being free and the first end 1216 a of the pliable member 1216being fixedly attached to the inserter tool 1200. The first end 1216 aof the pliable member 1216 attached to the inserter tool 1200 movesproximally with the inserter tool 1200 while pliable member 1216 bendsand the free second end 1216 b of the pliable member 1216 slides out ofthe groove 1222 such that the enclosed passage 1232 is open so as toallow exit of the suture 1250 therefrom, as shown in FIG. 64 . Thecavity 1218 extending substantially perpendicular to the longitudinalaxis of the inner shaft 1210 may help prevent the first end 1216 a ofthe pliable member 1216 from being detached from the inner shaft 1210during proximal movement of the inner shaft 1210 and bending of thepliable member 1216 causes thereby since the pliable member 1216 isbending away from the longitudinal axis of the inner shaft 1210 to openthe enclosed passage 1232. Continued proximal movement of the insertertool 1200 causes the entire pliable member 1216 to exit the patient'sbody along with the inserter tool 1200. With the enclosed passage 1232being open, the suture 1250 is freed from the enclosed passage 1232, andthus from the suture retention channel 1204, and can thus stay fixed inposition in the bone hole with the anchor 1202, as shown in FIG. 65 .Tails of the suture 1250 can be trimmed as desired. Although the suture1250 is shown distal to the anchor 1202 in FIG. 65 , the suture 1250 canbe fully or partially located within the anchor 1202, e.g., inembodiments in which the anchor 1202 has an open distal end.

The pliable member 1216 in this illustrated embodiment is passive suchthat the suture 1250 extends through the enclosed passage 1232 and isfreely slidable through the enclosed passage 1232 until the anchor 1202fixes the suture 1250 in position relative to the bone.

FIGS. 66-69 illustrate another embodiment of an inserter tool 1300 forknotless anchor insertion in a soft tissue repair surgical procedure.The inserter tool 1300 is generally configured and used similar to theinserter tool 1200 of FIGS. 49-54 , e.g., is configured to insert ananchor 1302 into a bone of a patient to secure a soft tissue relative tothe bone and includes a handle 1306, an outer shaft 1308 that extendsdistally from the handle 1306, an inner shaft 1310 that extends distallyfrom the handle 1306 and includes a notch formed therein that defines asuture retention channel 1304, a pliable member 1316 that cooperateswith the inner shaft 1310 to define an enclosed passage 1332, and asuture retention member defined by the handle 1306 and first and secondelastomeric cleats (only one of the elastomeric cleats 1336 a is shownin FIGS. 68 and 69 ) fixedly attached to the handle 1306. The anchor1302 is generally configured and used similar to the anchor 102 of FIG.1 . Although not shown in FIGS. 66-69 , the inserter tool 1300 alsoincludes, similar to the inserter tool 1200, a strike cap that extendsproximally from the handle 1306 and a locking mechanism configured tolock the outer shaft 1308 in position relative to the inner shaft 1310when the locking mechanism is in a locked position.

The pliable member 1316 has a first end fixedly attached to the handle1306 and has a second end that is free so as to not be fixedly attachedto the handle 1306. The inner shaft 1310 includes a groove 1322configured to releasably seat the second end of the pliable member 1316therein, similar to the groove 1222 that seats the second end 1216 a ofthe pliable member 1216 therein. The first end of the pliable member1316 is fixedly attached to an actuator 1314 at the handle 1306. Thefirst end of the pliable member 1316 can be attached to the actuator1314 in any of a variety of ways, similar to that discussed aboveregarding the first end 1216 a of the pliable member 1216 being fixedlyattached to the inner shaft 1210.

The pliable member 1216 extends from the actuator 1314 to the groove1322 within an inner lumen of the outer shaft 1308 in which the innershaft 1310 is disposed, as shown in FIGS. 66 and 68 . The inner shaft1310 includes a longitudinal channel 1320 that extends longitudinallyalong the inner shaft 1310 that is configured to seat the pliable member1216 therein. The pliable member 1216 bends to exit the longitudinalchannel 1320 to allow the second end of the pliable member 1216 to beseated in the inner shaft's groove 1322.

The pliable member 1216 of the inserter tool 1200 is a passive member,as discussed above. In this illustrated embodiment, the pliable member1316 is an active member. The pliable member 1316 is configured to beactively moved to open the enclosed passage 1332 using an actuator 1314.Actuation of the actuator 1314 is configured to move the pliable member1316 to open the enclosed passage 1332. The actuator 1314 is a slidabletrigger in this illustrated embodiment but can have otherconfigurations, e.g., a rotatable knob, a pullable lever, etc.

The actuator 1314 is configured to move between an unactuated positionand an actuated position. In the unactuated position, shown in FIG. 68 ,the pliable member 1316 is seated in the groove 1322 of the inner shaft1310 and the enclosed passage 1332 is present to receive a suturetherethrough. The suture can be positioned in the enclosed passage 1332similar to that discussed above regarding a suture being positioned inthe enclosed passage 1232. In the actuated position, shown in FIG. 69 ,the pliable member 1316 is not seated in the groove 1322 of the innershaft 1310 and the enclosed passage 1332 is open to allow the suture toexit the suture retention channel of the inner shaft 1310. In someembodiments, the pliable member 1316 is not stiff enough to bend andmove back into the groove 1322 if the actuator 1314 is actuated a secondtime to slide proximally. In other embodiments, the pliable member 1316has sufficient stiffness to bend and move back into the groove 1322 ifthe actuator 1314 is actuated a second time to slide proximally.

The handle 1306 includes a channel 1326 configured to slidably seat theactuator 1314 therein. The actuator 1314 is user-accessible outside ofthe channel 1326. The actuator 1314 is configured to slide proximallywithin the channel 1326 relative to the handle 1306, the outer shaft1308, and the inner shaft 1310 from the unactuated position to theactuated position. The proximal movement of the actuator 1314 isconfigured to cause the pliable member 1316 to move proximally relativeto the handle 1306, the outer shaft 1308, and the inner shaft 1310. Theproximal movement of the pliable member 1316 causes the second end ofthe pliable member 1316 to exit the groove 1322 of the inner shaft 1310,thereby opening the enclosed passage 1332.

With the suture coupled to the inserter tool 1300, and with the loadingaid removed if a loading aid was used to facilitate suture coupling tothe inserter tool 1300, the inserter tool 1300 can be used to insert thesuture and the anchor 1302 into a bone hole. In an exemplary embodimentof using the inserter tool 1300 to insert the suture and the anchor 1302into a bone hole, a drill or other bone removal tool is inserted into apatient's body to form the bone hole, similar to that discussed aboveregarding the inserter 100 of FIG. 1 .

The inserter tool 1300 is advanced distally into the body of the patientand positioned with the distal end of the inner shaft 1310 within thebone hole and thus with the enclosed passage 1332 within the bone hole.The suture that extends through the enclosed passage 1332 is thuspositioned in the bone hole before the anchor 1302 is secured in thebone hole. A bottom surface of the bone hole can act as a stop surfacethat stops distal movement of the inserter tool 1300 relative to thebone, similar to that discussed above regarding the inserter 100 of FIG.1 .

With the distal end of the inner shaft 1310 positioned in the bone hole,and prior to distal advancement of the anchor 1302 relative to the innershaft 1310, the suture can be tensioned as desired and can be retainedby the suture retention member of the inserter tool 1300.

With the distal end of the inner shaft 1310 positioned in the bone hole,the locking mechanism is moved from the locked position to the unlockedposition, as discussed above. The outer shaft 1308 is now free to moverelative to the inner shaft 1310 in response to a strike on the strikecap. With the distal end of the inner shaft 1310 positioned in the bonehole, the anchor 1302 is advanced distally into the bone hole bylongitudinally translating the anchor 1302 relative to the inner shaft1310 in a distal direction by striking the strike cap to distallyadvance the outer shaft 1308, similar to that discussed above regardingthe inserter 100 of FIG. 1 . The anchor 1302 in the bone hole traps thesuture between the exterior surface of the anchor 1302 and the bonesurface defining the bone hole.

After the anchor 1302 has been inserted into the bone hole, the actuator1314 is actuated, e.g., slid proximally in the handle's channel 1326, tomove the pliable member 1316 and open the enclosed passage 1332. Theproximal movement of the actuator 1314 causes the pliable member 1316 tomove proximally due to the second end of the pliable member 1316 beingfree and the first end of the pliable member 1316 being fixedly attachedto the actuator 1314. The first end of the pliable member 1316 attachedto the actuator 1314 moves proximally with the actuator 1314, and thefree second end of the pliable member 1316 slides out of the groove 1322such that the enclosed passage 1332 is open so as to allow exit of thesuture therefrom. With the enclosed passage 1332 being open, the sutureis allowed to exit the enclosed passage 1332, and thus also the sutureretention channel 1304.

With the enclosed passage 1332 open, e.g., after the actuation of theactuator 1314, the inserter tool 1300 is longitudinally translated in aproximal direction, e.g., pulled axially along a longitudinal axis ofthe inserter tool 1300, to be removed from the patient's body with theanchor 1302 and the suture remaining in the bone. The proximal movementof the inserter tool 1300 causes the entire pliable member 1316 to exitthe patient's body along with the inserter tool 1300. Tails of thesuture can be trimmed as desired.

FIGS. 70 and 71 illustrate another embodiment of an inserter tool 1400for knotless anchor insertion in a soft tissue repair surgicalprocedure. The inserter tool 1400 is generally configured and usedsimilar to the inserter tool 100 of FIG. 1 , e.g., is configured toinsert an anchor 1402 into a bone of a patient to secure a soft tissuerelative to the bone and includes a handle (not shown), an outer shaft(not shown) that extends distally from the handle, an inner shaft 1410that extends distally from the handle, a strike cap (not shown) thatextends proximally from the handle, a locking mechanism (not shown)configured to lock the outer shaft in position relative to the innershaft 1410 when the locking mechanism is in a locked position, and asuture retention member (not shown). The anchor 1402 is generallyconfigured and used similar to the anchor 102 of FIG. 1 .

In this illustrated embodiment, the inner shaft 1410 includes a firstcomponent 1410 a and a second component 1410 b that cooperate to definean enclosed passage 1432 that is configured to receive a suturetherethrough similar to the enclosed passages discussed above. FIG. 70shows the first and second components 1410 a, 1410 b in an engagedposition cooperating to define the enclosed passage 1432. The engagedposition is an initial position of the first and second components 1410a, 1410 b. Distal tips of the first and second components 1410 a, 1410 bare interlocked in the engaged position, which allows the enclosedpassage 1432 to be present. The first and second components 1410 a, 1410b are dovetailed to interlock in this illustrated embodiment but can beinterlocked in another way. FIG. 71 shows the first and secondcomponents 1410 a, 1410 b in a disengaged position in which the enclosedpassage 1432 is open. The second component 1410 b is configured to moverelative to the first component 1410 a to move from the engaged positionto the disengaged position.

The inserter tool 1400 includes an actuator (not shown) configured to beactuated to move the second component 1410 b relative to the firstcomponent 1410 a. The actuator is generally configured and used similarto the actuator 1214 of the inserter tool 1200, e.g., by being aslidable trigger or other actuator. The actuator is configured to movebetween an unactuated position, corresponding to the engaged position ofthe first and second components 1410 a, 1410 b, and an actuatedposition, corresponding to the disengaged position of the first andsecond components 1410 a, 1410 b.

With the suture coupled to the inserter tool 1400, and with the loadingaid removed if a loading aid was used to facilitate suture coupling tothe inserter tool 1400, the inserter tool 1400 can be used to insert thesuture and the anchor 1402 into a bone hole. In an exemplary embodimentof using the inserter tool 1400 to insert the suture and the anchor 1402into a bone hole, a drill or other bone removal tool is inserted into apatient's body to form the bone hole, similar to that discussed aboveregarding the inserter 100 of FIG. 1 .

The inserter tool 1400 is advanced distally into the body of the patientand positioned with the distal end of the inner shaft 1410 within thebone hole and thus with the enclosed passage 1432 within the bone hole.The suture that extends through the enclosed passage 1432 is thuspositioned in the bone hole before the anchor 1402 is secured in thebone hole. A bottom surface of the bone hole can act as a stop surfacethat stops distal movement of the inserter tool 1400 relative to thebone, similar to that discussed above regarding the inserter 100 of FIG.1 .

With the distal end of the inner shaft 1410 positioned in the bone hole,and prior to distal advancement of the anchor 1402 relative to the innershaft 1410, the suture can be tensioned as desired and can be retainedby the suture retention member of the inserter tool 1400.

With the distal end of the inner shaft 1410 positioned in the bone hole,the locking mechanism is moved from the locked position to the unlockedposition, as discussed above. The outer shaft is now free to moverelative to the inner shaft 1410 in response to a strike on the strikecap. With the distal end of the inner shaft 1410 positioned in the bonehole, the anchor 1402 is advanced distally into the bone hole bylongitudinally translating the anchor 1402 relative to the inner shaft1410 in a distal direction by striking the strike cap to distallyadvance the outer shaft, similar to that discussed above regarding theinserter 100 of FIG. 1 . The anchor 1402 in the bone hole traps thesuture between the exterior surface of the anchor 1402 and the bonesurface defining the bone hole.

After the anchor 1402 has been inserted into the bone hole, the actuatoris actuated, e.g., slid distally in the handle's channel or otherwiseactuated, to move the second component 1410 b distally relative to thefirst component 1410 b and thereby open the enclosed passage 1432. Withthe enclosed passage 1432 being open, the suture is allowed to exit theenclosed passage 1432.

With the enclosed passage 1432 open, e.g., after the actuation of theactuator, the inserter tool 1400 is longitudinally translated in aproximal direction, e.g., pulled axially along a longitudinal axis ofthe inserter tool 1400, to be removed from the patient's body with theanchor 1402 and the suture remaining in the bone. Tails of the suturecan be trimmed as desired.

The inserter tools 100, 500, 600, 700, 800, 900, 1000, 1200, 1300, 1400discussed above have linear outer and inner shafts but can have curvedouter and inner shafts, as mentioned above. Similarly, as also mentionedabove, the inserter tool 1100 has curved outer and inner shafts but canhave linear outer and inner shafts. FIGS. 72-79 illustrate anotherembodiment of an inserter tool 1500 having curved outer and inner shafts1508, 1510.

The inserter tool 1500 is for knotless anchor insertion in a soft tissuerepair surgical procedure and is the same as the inserter tool 1200 ofFIGS. 49-54 except for the curvature of the outer and inner shafts 1508,1510 (and an indicator related thereto, discussed below), e.g., isconfigured to insert the anchor 1202 into a bone of a patient to securea soft tissue relative to the bone and includes a handle 1506, the outershaft 1508 that extends distally from the handle 1506, the inner shaft1510 that extends distally from the handle 1506 and includes a notchformed therein that defines a suture retention channel, a pliable member1516 that cooperates with the inner shaft 1510 to define an enclosedpassage, a suture retention member 1534 defined by the handle 1506 andfirst and second elastomeric cleats 1536 a, 1536 b fixedly attached tothe handle 1506, a strike cap 1512 that extends proximally from thehandle 1506, and a locking mechanism 1538 configured to lock the outershaft 1508 in position relative to the inner shaft 1510 when the lockingmechanism is in a locked position.

The curved outer shaft 1508 in this illustrated embodiment is flexible,unlike the linear outer shaft 1208 of the inserter tool 1200. The outershaft 1508 being flexible facilitates the outer shaft's translationalong the curved inner shaft 1510.

FIG. 72 is similar to FIG. 49 and shows the locking mechanism 1538 in anunlocked position before the strike cap 1512 has been struck. FIGS. 73and 74 are similar to FIGS. 57 and 58 , respectively, and show thelocking mechanism 1538 in a locked position and show the loading aid1242 releasably attached to the inserter tool 1500. FIG. 75 is similarto FIG. 62 and shows the shows the locking mechanism 1538 in theunlocked position after the strike cap 1512 has been struck.

FIGS. 76-78 show an indicator 1540 on the handle 1506 includes a finprotruding from the handle 1506 and is curved in a same direction (shownby an arrow 1542) as the outer and inner shafts 1508, 1510. Since thehandle 1506 is located outside of a patient's body during use of theinserter tool 1500, the indicator 1540 at the handle 1506 is configuredto indicate the direction of the outer and inner shafts' curvature to auser, e.g., in the event that the outer and inner shafts' curvature isnot visible within the patient's body. FIG. 78 also shows a first suture1550 a seated in a first suture retention groove 1534 a defined by thehandle 1506 and the first elastomeric cleat 1536 a, and a second suture1550 b seated in a second suture retention groove 1534 b defined by thehandle 1506 and the second elastomeric cleat 1536 b.

FIG. 79 shows the outer shaft 1508 abutting the anchor 1202 before theanchor 1202 has been advanced distally into bone.

As mentioned above, any of a variety of anchors can be used with theinserter tools described herein. In an exemplary embodiment, the anchoris a tapered helical anchor. In general, a tapered helical anchor tapersradially inward in a distal direction such that a diameter of thetapered helical anchor at a proximal end of the tapered helical anchoris greater than a diameter of the tapered helical anchor at a distal endof the tapered helical anchor. The tapered helical anchor may thusachieve more cortical bone engagement than cancellous bone engagement,with the increased diameter proximal portion of the tapered helicalanchor engaging cortical bone that overlies (is proximal to) cancellousbone. Cortical bone is harder than cancellous bone, so greaterengagement of cortical bone than cancellous may better help secure thetapered helical anchor in the bone.

The tapered helical anchor includes a plurality of bone-engaging surfacefeatures, e.g., threads or other features. Each of the bone-engagingsurface features extends helically along a length of the tapered helicalanchor. Each of the bone-engaging surface features is independent fromthe other of the tapered helical anchor's bone-engaging surfacefeatures. Each of the bone-engaging surface features is thus configuredto form its own path in bone, which may help minimize unwanted shearingof both cortical and cancellous bone strata. The combination of thedistal tapering of the tapered helical anchor and the independenthelical bone-engaging surface features allows the tapered helical anchorto progressively engage new areas of bone as the tapered helical anchoris advanced distally into the bone, which may create radial stressthrough axial displacement and increase fixation of the tapered helicalanchor in bone, particularly in cancellous bone that is softer thancortical bone.

In some embodiments each of the tapered helical anchor's bone-engagingsurface features can extend along an entire length of the taperedhelical anchor. In other embodiments, each of the tapered helicalanchor's bone-engaging surface features can extend along only a partiallength of the tapered helical anchor such that a proximal portion of thetapered helical anchor includes the bone-engaging surface features,e.g., is threaded, and a distal portion of the tapered helical anchorlacks any threads, e.g., is unthreaded. The distal portion of thetapered helical anchor lacking bone-engaging surface features mayfacilitate guiding of the tapered helical anchor into a pre-formed bonehole.

The tapered helical anchor is configured to be advanced distally intobone using an inserter tool as described herein, where the inserter toolis configured to longitudinally translate an anchor into bone. Thetapered helical anchor can instead, however, be rotationally driven intobone.

FIGS. 80 and 81 illustrate one embodiment of a tapered helical anchor1600. The tapered helical anchor 1600 includes six helical bone-engagingsurface features 1602, in the form of threads, that are independent fromone another and that each extend helically around the tapered helicalanchor 1600. The threads 1602 each extend along an entire length of thetapered helical anchor 1600. The tapered helical anchor 1600 has riflingfor cold-forming the threads 1602. The tapered helical anchor 1600tapers radially inward in a distal direction such that a diameter of thetapered helical anchor 1600 at a proximal end 1604 of the taperedhelical anchor 1600 is greater than a diameter of the tapered helicalanchor 1600 at a distal end 1606 of the tapered helical anchor 1600. Thetapered helical anchor 1600 is cannulated.

FIGS. 82 and 83 illustrate another embodiment of a tapered helicalanchor 1700. The tapered helical anchor 1700 includes six helicalbone-engaging surface features 1702, in the form of threads, that areindependent from one another and that each extend helically around thetapered helical anchor 1700. The threads 1702 each extend along anentire length of the tapered helical anchor 1700. The threads 1702 havegreater depth than the threads 1602 of FIGS. 80 and 81 . The taperedhelical anchor 1700 has rifling for cold-forming the threads 1702. Thetapered helical anchor 1700 tapers radially inward in a distal directionsuch that a diameter of the tapered helical anchor at a proximal end1704 of the tapered helical anchor 1700 is greater than a diameter ofthe tapered helical anchor at a distal end 1706 of the tapered helicalanchor 1700. The tapered helical anchor 1700 is cannulated.

FIGS. 84 and 85 illustrate another embodiment of a tapered helicalanchor 1800. The tapered helical anchor 1800 includes nine helicalbone-engaging surface features 1802, in the form of threads, that areindependent from one another and that each extend helically around thetapered helical anchor 1800. The threads 1802 each extend along anentire length of the tapered helical anchor 1800. The threads 1802 havea higher pitch than the threads 1602 of FIGS. 80 and 81 . The threads1802 have a same depth as the threads 1602 of FIGS. 80 and 81 . Thetapered helical anchor 1800 has rifling for cold-forming the threads1802. The tapered helical anchor 1800 tapers radially inward in a distaldirection such that a diameter of the tapered helical anchor at aproximal end 1804 of the tapered helical anchor 1800 is greater than adiameter of the tapered helical anchor at a distal end 1806 of thetapered helical anchor 1800. The tapered helical anchor 1800 iscannulated.

FIGS. 86 and 87 illustrate another embodiment of a tapered helicalanchor 1900. The tapered helical anchor 1900 includes nine helicalbone-engaging surface features 1902, in the form of threads, that areindependent from one another and that each extend helically around thetapered helical anchor 1900. The threads 1902 each extend along anentire length of the tapered helical anchor 1900. The threads 1902 havea higher pitch than the threads 1702 of FIGS. 82 and 83 . The threads1902 have a same depth as the threads 1702 of FIGS. 82 and 83 . Thetapered helical anchor 1900 has rifling for cold-forming the threads1902. The tapered helical anchor 1900 tapers radially inward in a distaldirection such that a diameter of the tapered helical anchor at aproximal end 1904 of the tapered helical anchor 1900 is greater than adiameter of the tapered helical anchor at a distal end 1906 of thetapered helical anchor 1900. The tapered helical anchor 1900 iscannulated.

FIGS. 88 and 89 illustrate another embodiment of a tapered helicalanchor 2000. The tapered helical anchor 2000 includes six helicalbone-engaging surface features 2002, in the form of threads, that areindependent from one another and that each extend helically around thetapered helical anchor 2000. The threads 2002 each extend along anentire length of the tapered helical anchor 2000. The tapered helicalanchor 2000 includes omnidirectional cutaways along each of the threads2002 such that the threads 2002 are discontinuous, unlike the threads1602, 1702, 1802, 1902 that are continuous. The omnidirectional cutawaysare configured to allow the threads 2002 to each repeatedly positiveengage bone, which may improve fixation of the tapered helical anchor2002 in the bone. The tapered helical anchor 2000 tapers radially inwardin a distal direction such that a diameter of the tapered helical anchorat a proximal end 2004 of the tapered helical anchor 2000 is greaterthan a diameter of the tapered helical anchor at a distal end 2006 ofthe tapered helical anchor 2000. The tapered helical anchor 2000 iscannulated.

FIGS. 90 and 91 illustrate another embodiment of a tapered helicalanchor 2100. The tapered helical anchor 2100 includes six helicalbone-engaging surface features 2102, in the form of threads, that areindependent from one another and that each extend helically around thetapered helical anchor 2100. The threads 2102 each extend along apartial length of the tapered helical anchor 2100 such that a proximalportion of the tapered helical anchor 2100 is threaded and a distalportion of the tapered helical anchor 2100 is unthreaded. The taperedhelical anchor 2100 tapers radially inward in a distal direction suchthat a diameter of the tapered helical anchor at a proximal end 2104 ofthe tapered helical anchor 2100 is greater than a diameter of thetapered helical anchor at a distal end 2106 of the tapered helicalanchor 2100. The tapered helical anchor 2100 is cannulated.

FIG. 92 illustrates another embodiment of a tapered helical anchor 2200.The tapered helical anchor 2200 includes six helical bone-engagingsurface features 2202, in the form of threads, that are independent fromone another and that each extend helically around the tapered helicalanchor 2200. The threads 2202 each extend along a partial length of thetapered helical anchor 2200 such that a proximal portion of the taperedhelical anchor 2200 is threaded and a distal portion of the taperedhelical anchor 2200 is unthreaded. The unthreaded distal portion of thetapered helical anchor 2200 is forked with a pair of distal arms 2208extending distally from the threaded proximal portion of the taperedhelical anchor 2200. The distal arms 2208 are configured to eachpenetrate into bone, e.g., at a distal bottom of a bone hole in whichthe tapered distal anchor 2200 is disposed, which may help fix thetapered helical anchor 2200 in the bone. The tapered helical anchor 2200tapers radially inward in a distal direction such that a diameter of thetapered helical anchor at a proximal end 2204 of the tapered helicalanchor 2200 is greater than a diameter of the tapered helical anchor ata distal end 2206 of the tapered helical anchor 2200. The taperedhelical anchor 2200 is cannulated.

FIG. 92 shows the tapered helical anchor 2200 as a standalone element.FIG. 93 shows the tapered helical anchor 2200 releasably coupled to theinserter tool 100 of FIG. 1 at an initial position, e.g., before theouter shaft 108 has distally advanced the tapered helical anchor 2200.FIG. 94 shows the tapered helical anchor 220 after the outer shaft 108has distally advanced the tapered helical anchor 2200 and before theinserter tool 100 is moved proximally relative to the tapered helicalanchor 2200. Although FIGS. 93 and 94 show the tapered helical anchor2200 used with the inserter tool 100 of FIG. 1 , the tapered helicalanchor 2200 can, as mentioned above, be used with another inserter tool.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, a device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

The devices described herein can be processed before use. First, a newor used instrument is obtained and if necessary cleaned. The instrumentcan then be sterilized. In one sterilization technique, the instrumentis placed in a closed and sealed container, such as a plastic or TYVEKbag. The container and instrument are then placed in a field ofradiation or toxic gas that can penetrate the container, such asEthylene Oxide, gamma radiation, x-rays, or high-energy electrons. Theradiation kills bacteria on the instrument and in the container. Thesterilized instrument can then be stored in the sterile container. Thesealed container keeps the instrument sterile until it is opened in amedical facility.

Sterilization can be done by any number of ways known to those skilledin the art including beta or gamma radiation, ethylene oxide, steam, anda liquid bath (e.g., cold soak).

A person skilled in the art will appreciate that the implementationsdescribed herein have application in conventional minimally-invasive andopen surgical instrumentation as well application in robotic-assistedsurgery.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety for all purposes.

What is claimed is:
 1. A surgical system, comprising: a handle; an outershaft extending distally from the handle and including an inner lumen;an inner shaft extending distally from the handle, the inner shaft beingpositioned in the inner lumen of the outer shaft, a distal end of theinner shaft being positioned distal to an open distal end of the outershaft; a pliable member having a first state in which the pliable membercooperates with the distal end of the inner shaft to define an enclosedpassage that is configured to seat a suture therethrough; and an anchorconfigured to be implanted in bone, the anchor including an inner lumen,and the inner shaft being positioned in the inner lumen of the anchor;wherein the outer shaft is configured to translate relative to the innershaft and thereby cause the anchor to translate distally into a bonehole; the inner shaft includes a pair of opposed distal arms that defineleft and right sides of the enclosed passage; and wherein the pliablemember in the first state is configured to bend relative to the distalarms to open the enclosed passage.
 2. The system of claim 1, wherein thepliable member in the first state is configured to automatically unfoldin response to longitudinal and proximal translation of the inner shaftrelative to the anchor and thereby cause the enclosed passage to beopened.
 3. The system of claim 1, wherein a first end of the pliablemember is fixedly attached to the handle, and a second end of thepliable member is freely movable relative to the handle and the innershaft.
 4. The system of claim 3, wherein, with the pliable member in thefirst state, the second end of the pliable member is configured toautomatically bend relative to the inner shaft in response tolongitudinal and proximal translation of the inner shaft relative to theanchor.
 5. The system of claim 1, wherein a proximal surface of theinner shaft defines a proximal side of the enclosed passage; the pliablemember defines a distal side of the enclosed passage; and the distalarms each extend between the proximal and distal sides of the enclosedpassage.
 6. The system of claim 1, further comprising a wire operativelycoupled to the pliable member; and an actuator at the handle configuredto be actuated and thereby cause the wire to move proximally, wherein,with the pliable member in the first state, the proximal movement of thewire is configured to cause bending of the pliable member such that theenclosed passage is opened.
 7. The system of claim 1, wherein thepliable member comprises a metal wire, a braided fabric, or a textilestrand.
 8. The system of claim 1, wherein the anchor has a plurality ofindependent external bone-engaging surface features that helicallyextend along a length of the anchor and that are each configured toengage the bone.
 9. The system of claim 1, wherein the anchor has aplurality of bone-engaging surface features and a plurality of gussets.10. The system of claim 1, further comprising the suture seated throughthe enclosed passage.
 11. The system of claim 10, wherein the suture isseated through the enclosed passage prior to the distal end of the innershaft being positioned in the bone hole and is seated through theenclosed passage after the translation of the outer shaft such that theanchor traps the suture between an exterior surface of the anchor and awall of the bone hole.
 12. The system of claim 10, wherein after thetranslation of the outer shaft and with the pliable member in the firststate, the inner shaft is configured to translate longitudinally andproximally relative to the anchor in the bone hole; and the translationof the inner shaft is configured to automatically cause the bending ofthe pliable member, thereby allowing release of the suture.
 13. Thesystem of claim 1, further comprising the suture and a loading aid;wherein the loading aid is configured to releasably couple to the innershaft and is configured to guide the suture through the enclosedpassage.
 14. The system of claim 2, wherein the outer shaft isconfigured to translate longitudinally and proximally with thelongitudinal and proximal translation of the inner shaft.
 15. A surgicalsystem, comprising: a handle; an outer shaft extending distally from thehandle and including an inner lumen; an inner shaft extending distallyfrom the handle, the inner shaft being positioned in the inner lumen ofthe outer shaft, a distal end of the inner shaft being positioned distalto an open distal end of the outer shaft; a pliable member having afirst state in which the pliable member cooperates with the distal endof the inner shaft to define an enclosed passage that is configured toseat a suture therethrough; and an anchor configured to be implanted inbone, the anchor including an inner lumen, and the inner shaft beingpositioned in the inner lumen of the anchor; wherein the pliable memberin the first state is configured to bend to open the enclosed passage;and wherein, with the pliable member in the first state, the outer shaftis configured to translate relative to the inner shaft and thereby causethe anchor to translate distally into a bone hole and thereafter theouter shaft and the inner shaft are configured to longitudinally andproximally translate relative to the anchor and removed from the bone,the longitudinal and proximal translation of the outer shaft and theinner shaft being configured to cause the pliable member to bend and theenclosed passage to be opened.